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

Model Number XI

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

Two force bipolar instruments failed to function properly during a robotic bariatric case.They are both 'reposable' instruments with various lives remaining.These are being sent back to intuitive for reimbursement.Fda safety report id# (b)(4).

• Brand Name: DA VINCI FORCE BIPOLAR
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 12540257
• MDR Text Key: 273817053
• Report Number: MW5104235
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/23/2021
• 2 Devices were Involved in the Event: 1 2

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: #471405
• Device Lot Number: N11210603/N10210419 (VER 06)
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1