MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. XI FENESTRATED BIPOLAR FORCEPS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 471205

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Surgeon using xi fenestrated bipolar forceps in patient when an articulating wire broke.Able to continue to move instrument with no problem and removed from port site.Fda safety report id# (b)(4).

• Brand Name: XI FENESTRATED BIPOLAR FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 11655410
• MDR Text Key: 245368980
• Report Number: MW5100725
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR