MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 471205-17

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Cable on the tip broken when in the patient.Surgeon was just grasping tissue.Fda safety report id# (b)(4).

• Brand Name: INTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA
• MDR Report Key: 13334106
• MDR Text Key: 284621576
• Report Number: MW5106895
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Lot Number: N102105310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1