Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database

Pierce, Hudson; Roberts, Brittany; Scherr, Douglas S.; Barbieri, Christopher E.; Anger, Jennifer T.; McClure, Timothy; Chughtai, Bilal

doi:10.1007/s11701-020-01088-1

Cited by 5 publications

(3 citation statements)

References 15 publications

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“…In our experience, this rate was higher (3%) but the consequences were limited, with only 1 malfunction leading to laparotomy conversion. In fact, robot malfunctions rarely lead to major injuries (0.0002%) and none have been reported to lead to death 33,34 . Robot-specific complications in children are therefore extremely rare and have not occurred in large pediatric studies, including the current study.…”

Section: Discussionmentioning

confidence: 67%

“…In fact, robot malfunctions rarely lead to major injuries (0.0002%) and none have been reported to lead to death. 33,34 Robot-specific complications in children are therefore extremely rare and have not occurred in large pediatric studies, including the current study. Multidisciplinary staff training is critical in avoiding position-related complications, such as a small child being obscured from external view and emergency access.…”

Section: Discussionmentioning

confidence: 75%

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Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study

Vinit

Vatta²,

Broch³

et al. 2023

Annals of Surgery

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To report one-year morbidity of robotic-assisted laparoscopic surgery (RALS) in a dedicated, multidisciplinary, pediatric robotic surgery program. Summary Background Data. RALS in pediatric surgery is expanding, but data on morbidity in children is limited. Methods: All children who underwent RALS (Da Vinci Xi, Intuitive Surgical, USA) were prospectively included (October 2016 to May 2020; follow-up ≥1 year). Analyzed data: patient characteristics, surgical indication/procedure, intraoperative adverse events (ClassIntra classification), blood transfusion, hospital stay, postoperative complications (Clavien-Dindo). Results: Three hundred consecutive surgeries were included: urology/ gynecology (n=105), digestive surgery (n=83), oncology (n=66), ENT surgery (n=28), thoracic surgery (n=18). Median age and weight at surgery were 9.5 [interquartile range (IQR)=8.8] years and 31 [IQR=29.3] kg, respectively. Over one year, 65 (22%) children presented with ≥1 complication, with Clavien-Dindo ≥III in 14/300 (5%) children at ≤30 days, 7/300 (2%) at 30-90 days, and 12/300 (4%) at >90 days. Perioperative transfusion was necessary in 15 (5%) children, mostly oncological (n=8). Eight (3%) robotic malfunctions were noted, one leading to conversion (laparotomy). Overall conversion rate was 4%. ASA ≥3, weight ≤15 kg, and surgical oncology did not significantly increase the conversion rate, complications, or intraoperative adverse events (ClassIntra ≥2). ASA score was significantly higher in children with complications (Clavien-Dindo ≥III) than without (p=0.01). Median hospital stay was 2 [IQR=3] days. Three children died after a median follow-up of 20 [IQR=16] months. Conclusions: RALS is safe, even in the most vulnerable children with a wide scope of indications, age, and weight. Robot-specific complications or malfunctions are scarce.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 75%

Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study

Vinit

Vatta²,

Broch³

et al. 2023

Annals of Surgery

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“…Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 . A comprehensive flowchart of this selection process is depicted in Figure 1.…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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Complications of Robotic Instrument Malfunctions

Lee,

Eun

2024

Robotic Urology

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Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database

Cited by 5 publications

References 15 publications

Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study

Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Complications of Robotic Instrument Malfunctions

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