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

Catalog Number 470194

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

The mega needle driver broke while in use and inside the patient.One of the cables that opens the jaws of the instrument snapped while suturing.The instrument was removed, and a new instrument was opened to complete the surgery.

• 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: 11699798
• MDR Text Key: 246567817
• Report Number: 11699798
• 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: 04/19/2021

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: Health Professional
• Device Catalogue Number: 470194
• Device Lot Number: N10201110 0119
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 106