MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI CADIERE FORCEP; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number XI

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This xi robotic cadiere forcep has a broken cable.Most likely it was noticed during its time in sterile processing as no paperwork was filed in the operating room suite.I will return this instrument to intuitive for reimbursement of remaining lives.Fda safety report id# (b)(4).

• Brand Name: DA VINCI CADIERE FORCEP
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale 94086
• MDR Report Key: 13118734
• MDR Text Key: 283139580
• Report Number: MW5106386
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XI
• Device Catalogue Number: 471049
• Device Lot Number: N10210104 0079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1