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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

While surgery was in progress, endowrist force bipolar was noted to be broken at jaw.The instrument was removed from the abdomen of the patient.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 11964849
• MDR Text Key: 255070383
• Report Number: 11964849
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA