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

Model Number 470184

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 01/16/2018

Event Type  malfunction  

Event Description

Davinci xi permanent cautery spatula had exposed wire cauterizing tissue.Doctor noticed and immediately called to robot rep.Rep came into the operating room and examined the equipment.Repair request submitted and instrument tagged.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7391910
• MDR Text Key: 104176164
• Report Number: 7391910
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 470184
• Device Lot Number: N10170608
• Other Device ID Number: PERMANENT CAUTERY SPATULA
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 70