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

Model Number 470205

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  Injury  

Event Description

Fenestrated bipolar malfunction.After multiple attempts of troubleshooting bipolar the surgeon noticed a single piece of cable sticking out of the jaws of the instrument.The instrument would not release after several attempts of troubleshooting this new issue.Eventually we learned the metal portion of the instrument was lifting away from the shaft alerting the davinci of an obstruction.The surgeon was able to safely remove the instrument and its entirety along with the metal trocar.Fda safety report id# (b)(4).

• Brand Name: FENESTRATED BIPOLAR FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 10055852
• MDR Text Key: 191115189
• Report Number: MW5094492
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205
• Device Catalogue Number: 470205
• Device Lot Number: N11190806 0061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR