MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI PERMANENT CAUTERY HOOK; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number XI

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Xi robotic instrument (permanenty cautery hook) failed to conduct electricity during a gastric bypass case.Unsuccessful troubleshooting attempted; 4/10 lives remaining on instrument.I will return to intuitive to attempt reimbursement for remaining lives.No patient injury incurred.Another instrument opened to complete the case.Fda safety report id# (b)(4).

• Brand Name: DA VINCI PERMANENT CAUTERY HOOK
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 13394791
• MDR Text Key: 284961870
• Report Number: MW5107074
• 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: 01/26/2022

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 Model Number: XI
• Device Catalogue Number: 470183
• Device Lot Number: N11210927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1