Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery

O’Hanlan, Katherine A.; Bassett, Paul

doi:10.4293/jsls.2022.00033

Cited by 5 publications

(6 citation statements)

References 22 publications

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“…- Adhesions formation: although OC is designed to be absorbed over time, in some cases, it may not fully degrade, leading to the formation of adhesion between tissues and organs; when OC comes into contact with nearby tissues, it may cause them to adhere together during the healing process; these adhesions may cause complications such as nerve compression, pain and interference with normal tissue function ( 5 , 8 , 9 ).…”

Section: Issues Related With the Use Of Ocmentioning

confidence: 99%

Commentary: A lymph node mediastinal foreign body reaction mimicking nodal metastasis: a case series

Franceschini

2023

Front. Med.

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Section: Issues Related With the Use Of Ocmentioning

confidence: 99%

Commentary: A lymph node mediastinal foreign body reaction mimicking nodal metastasis: a case series

Franceschini

2023

Front. Med.

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“…The Manufacturer and User Facility Device Experience (MAUDE) database in the United States is a prospectively maintained library of anonymously reported failures related to surgical devices 9 . This inventory of adverse events can serve to provide valuable learning lessons across a wide range of surgical disciplines 10 . While there are a number of studies examining findings relevant to urological surgery, to our knowledge, there are none dedicated to this category of instruments and accessories used so widely in endourology.…”

Section: Introductionmentioning

confidence: 99%

“… 9 This inventory of adverse events can serve to provide valuable learning lessons across a wide range of surgical disciplines. 10 While there are a number of studies examining findings relevant to urological surgery, to our knowledge, there are none dedicated to this category of instruments and accessories used so widely in endourology.…”

Section: Introductionmentioning

confidence: 99%

Adverse events related to accessory devices used during ureteroscopy: Findings from a 10‐year analysis of the Manufacturer and User Facility Device Experience (MAUDE) database

et al. 2023

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ObjectivesThe objective of this study was to evaluate adverse events and device events related to accessories used during ureteroscopy (URS).Materials and methodsAnalysis was performed of the records available in the Manufacturer and User Facility Device Experience database in the United States. Information was collected on characteristics of problem, timing, manufacturer verdict, successful completion of planned surgery, prolonged anaesthesia and injury to patient or staff.ResultsFive‐hundred seventy‐one events related to URS accessories were recorded. These were associated with the following devices: baskets (n = 347), access sheath (n = 86), guidewires (n = 78), balloon dilators (n = 27), ARDs (n = 17) and ureteral catheters (n = 16). Of the events, 12.7% resulted in patient injuries. Forty‐eight per cent of the events resulted in prolonged anaesthesia, but the planned surgery was successfully completed in 78.4% of all cases. Collectively, the manufacturers accepted responsibility due to actual device failure in only 0.5% of cases. Common problems for baskets were failure to deploy (39.5%) and complete detachment of basket head (34.6%) and partial breakage of the basket head (12.4%). Of the basket group, 4.3% required open or percutaneous surgery to remove stuck basket. Full break of the body of the access sheath occurred in 41.9% and complete ureteral avulsion in 3.5%. For balloon dilators, there was a burst in 37% of cases. Broken guidewires were associated with 11.5% requiring repeat intervention for retrieval and 6.4% required JJ stent due to perforation to the collecting system. No injuries to operating staff were recorded with accessory usage.ConclusionAccessories used during URS are fragile. Potential for serious injury does exist as a direct result of their use. Surgeons should familiarise themselves with these events and how they can be prevented.

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“…On the other hand, there is a worry that some forms of fibrin sealants may have negative consequences, such as leaving deadly air pockets inside the body. Warnings have been issued by the Food and Drug Administration (FDA) in the USA regarding the development of potentially fatal air or gas emboli following the use of fibrin sealant aerosol sprays during surgery ( 11 ). The risks of employing sprays too closely to exposed tissue surfaces and at pressures higher than those advised by the makers have been made clear to users of the goods.…”

Section: Introductionmentioning

confidence: 99%

The safety and efficacy of fibrin sealant for thyroidectomy: a systematic review and meta-analysis of randomized controlled trials

Koerniawan,

Candrawinata,

Tjahyanto

et al. 2023

Front. Surg.

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Fibrin sealants have recently been thoroughly studied in several surgical specialties; however, results are conflicting. We aimed to examine the safety and efficacy of fibrin sealant patients having thyroidectomies. A thorough, systematic literature search was carried out using the terms thyroidectomy and fibrin sealant using PubMed, Cochrane Library, and Clinicaltrials.gov on December 25, 2022. The primary outcome of interest in this review was the amount of drainage, whereas hospitalization, the length of drain retention, and temporary dysphonia were secondary outcomes. Our meta-analysis (n = 249) showed that application of fibrin sealant is associated with lesser total drainage [SMD −2.76 (−4.83, −0.69); P = 0.009; I2 97%], but not with retention time of drainage [SMD −2.35 (−4.71, 0.01); P = 0.05; I2 98%], hospitalization time [SMD −1.65 (−3.70, 0.41); P = 0.12; I2 97%], and transient dysphonia [RR 1.01 (0.27, 3.82); P = 0.99; I2 0%]. The systematic review found that the use of fibrin sealant in thyroid surgery is positive in total volume drainage but not with the retention time of drainage, hospitalization time, and transient dysphonia. It is notable to remember that this interpretation is complicated by uneven, occasionally subpar technique and trial reporting, according to this systematic review's findings.

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Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery

Cited by 5 publications

References 22 publications

Commentary: A lymph node mediastinal foreign body reaction mimicking nodal metastasis: a case series

Commentary: A lymph node mediastinal foreign body reaction mimicking nodal metastasis: a case series

Adverse events related to accessory devices used during ureteroscopy: Findings from a 10‐year analysis of the Manufacturer and User Facility Device Experience (MAUDE) database

The safety and efficacy of fibrin sealant for thyroidectomy: a systematic review and meta-analysis of randomized controlled trials

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