BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15686262 · Received October 27, 2022

    Report

    Report Number
    2955842-2022-14907
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    January 30, 2022
    Report Date
    September 28, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    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 DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. FA FOUND THE PRIMARY FINDING OF COULD NOT REPRODUCE ¿ DOES NOT MATCH COMPLAINT DESCRIPTION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION WAS PERFORMED AND NO LOOSE CABLES WERE OBSERVED. NO ISSUES WITH MANUAL ARTICULATION OF THE INSTRUMENT'S INPUTS WERE OBSERVED. THE GRIP TIPS MOVED ACCORDINGLY. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE ROOT CAUSE IS NON-DEVICE RELATED FACTORS. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE DAMAGE OF THE CONDUCTOR WIRE¿S INSULATION. THE DAMAGE IS LOCATED AT THE DISTAL END. AS A RESULT, THE INTERNAL WIRES ARE EXPOSED. ELECTRICAL CONTINUITY WAS PERFORMED AND PASSED. NO THERMAL DAMAGE WAS OBSERVED. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS ON THE MAIN TUBE. THE SCRATCH MARKS WERE .153¿ - .219¿ IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THE ROOT CAUSE OF SCRATCH MARKS /ABRASIONS INSTRUMENT MAIN TUBE IS TYPICALLY ATTRIBUTED TO THE USER. A REVIEW OF THE INSTRUMENT LOG WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4). THE INSTRUMENT HAD 5 USES REMAINING AFTER LAST USE. NO PHOTO OR VIDEO WAS PROVIDED BY THE SITE FOR REVIEW. THIS COMPLAINT HAS CHANGED TO A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT HAD CONDUCTOR WIRE DAMAGE. THE DAMAGED/BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WIRE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO BE LOOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) FOLLOWED-UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT, WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY. PATIENT DEMOGRAPHICS AND MEDICAL HISTORY WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796642 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10211018 00886874119808

    Patients

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