MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST; SYSTEM, SURGICAL, COMPUTER

Catalog Number 470205

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2018

Event Type  malfunction  

Event Description

While performing a robotic low anterior colon resection with doctor, it was noticed that the tip of a robotic fenestrated bipolar forceps had broken off.The broken instrument was immediately removed and it was written on the board that a tip was missing.X-ray was called as the surgery was ending, but was then cancelled as the surgeon manually found and removed the broken tip.These devices can be reused ten times.This was the 10th time for this particular device.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1450 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7263139
• MDR Text Key: 99800693
• Report Number: 7263139
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 470205
• Device Lot Number: N11170908 0147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 66