BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17050816 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15616
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF FBF HAD THERMAL DAMAGE. FAILURE ANALYSIS (FA) FOUND THE PRIMARY FAILURE OF YAW PULLEY THERMAL DAMAGE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE YAW PULLEY. NO DAMAGE WAS FOUND TO THE CONDUCTOR WIRES. THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST. THE PROBABLE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE OF THE DEVICE. THE COMPLAINT REGARDING INSTRUMENT HAD THERMAL DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATED THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THERMAL DAMAGE IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE. THERMAL DAMAGE CAN ALSO RESULT DUE TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERMAL DAMAGE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER NOTICED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD THERMAL DAMAGE JUST BELOW THE INDUSTRIES. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS CHECKED BEFORE USE AND NOTHING ABNORMAL OBSERVED. THERE WAS NO DAMAGED CABLE. THERE WAS NO LOSS OF CAUTERY ASSOCIATED WITH A BROKEN/LOOSE CABLE. THE THERMAL DAMAGE IS LOCATED ON THE BEIGE PART, JUST BELOW THE JAWS OF THE FENESTRATED FORCEPS. NO INFORMATION IS AVAILABLE ABOUT WHETHER THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR TOOL DURING THE OPERATION. SINCE THE THERMAL DAMAGE ONLY BECAME APPARENT DURING THE CENTRAL PROCESSING, THE ENTIRE OPERATION WAS CARRIED OUT WITH THE SAME INSTRUMENT. NO PHOTOGRAPHS OF THE INSTRUMENT OR A VIDEO RECORDING OF THE PROCEDURE IS AVAILABLE TO THE ISI FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649349 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K13220718 0084 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES