Global robotic experience and the type of surgical system impact the types of robotic malfunctions and their clinical consequences: An FDA MAUDE review

BJU International

Volumn 109, Issue 8, 2012, Pages 1222-1227

  Lucas, Steven M ^a   Pattison, Erik A ^a   Sundaram, Chandru P ^a  

^a INDIANA UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Complications; Device failures; MAUDE database; Robotic surgery

Indexed keywords

ARTICLE; COMPUTER ASSISTED SURGERY; COMPUTER SYSTEM; CONTROLLED STUDY; DEVICE SAFETY; DISEASE ASSOCIATION; EQUIPMENT DESIGN; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERMETHOD COMPARISON; LAPAROSCOPIC SURGERY; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PATIENT MONITORING; PATIENT SAFETY; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; ROBOTICS; SURGICAL EQUIPMENT; SURGICAL MORTALITY;

EID: 84859470725     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2011.10692.x     Document Type: Article

References (12)

1. Menon M, Tewari A. Robotic radical prostatectomy and the Vattikuti Urology Institute technique: an interim analysis of results and technical points. Urology 2003; 61 (Suppl. 1): 15-20 (Pubitemid 36349125)
2. Intuitive Surgical. Investor Report 2009
3. Lavery HJ, Thaly R, Albala D et al. Robotic equipment malfunction during robotic prostatectomy: a multi-institutional study. J Endourol 2008; 22: 2165-8
4. Gurtcheff SE. Introduction to the MAUDE database. Clin Obstet Gynecol 2008; 51: 120-3 (Pubitemid 351640169)
5. Diehl DL, Tierney WM, Adler DG et al. The role of the U.S. Food and Drug Administration in device evaluation and monitoring. Gastrointest Endosc 2010; 72: 5-10
6. Park SY, Cho KS, Lee SW, Soh BH, Rha KH. Intraoperative breakage of needle driver jaw during robotic-assisted laparoscopic radical prostatectomy. Urology 2008; 71: 168. e5-6
7. Ostrzenski A. An intraoperative method of localizing a missing piece of a broken laparoscopic instrument. Am J Obstet Gynecol 1997; 176: 726-7 (Pubitemid 27147197)
8. Nayyar R, Gupta NP. Critical appraisal of technical problems with robotic urological surgery. BJU Int 2010; 105: 1710-3
9. Kim WT, Ham WS, Jeong W, Song HJ, Rha KH, Choi YD. Failure and malfunction of da Vinci Surgical systems during various robotic surgeries: experience from six departments at a single institute. Urology 2009; 74: 1234-7
10. Andonian S, Okeke Z, Okeke DA et al. Device failures associated with patient injuries during robot-assisted laparoscopic surgeries: a comprehensive review of FDA MAUDE database. Can J Urol 2008; 15: 3912-6
11. Zorn KC, Gofrit ON, Orvieto MA et al. Da Vinci robot error and failure rates: single institution experience on a single three-arm robot unit of more than 700 consecutive robot-assisted laparoscopic radical prostatectomies. J Endourol 2007; 21: 1341-4 (Pubitemid 350191375)
12. Borden LS Jr, Kozlowski PM, Porter CR, Corman JM. Mechanical failure rate of da Vinci robotic system. Can J Urol 2007; 14: 3499-501