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

Catalog Number 471205

Device Problem Break (1069)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

The case monday (b)(6) 2022 was involving a fenestrated bipolar forceps arm for the davinci robot.Once the instrument had been inserted into the patient, the surgeon noted that part of the tip was missing.Fda safety report id # (b)(4).

• Brand Name: DAVINCI XI FENESTRATED BIPOLAR FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 13549614
• MDR Text Key: 285843513
• Report Number: MW5107545
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2022

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 Catalogue Number: 471205
• Device Lot Number: 11210426-0256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1