MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST HOT SHEARS; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 400180

Device Problems Arcing (2583); Torn Material (3024)

Patient Problems Burn(s) (1757); Hemorrhage/Bleeding (1888)

Event Date 05/30/2017

Event Type  malfunction  

Event Description

There was a small tear in the scissor tip cover for robotic wrist instrument.When surgeon activated cautery he noticed an arc to the right iliac vein causing small 2-3 mm partial thickness cautery injury to the right external iliac vein.The vascular surgeon was contacted by phone and advised oversewing a fatty patch of tissue to the vein as no active bleeding was present.

• Brand Name: ENDOWRIST HOT SHEARS
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6680931
• MDR Text Key: 78847903
• Report Number: 6680931
• 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: Other
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: M10170324
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR