BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15130632 · Received July 29, 2022

    Report

    Report Number
    2955842-2022-13233
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    April 6, 2022
    Report Date
    June 30, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE .021¿ - .121¿ IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THE ROOT CAUSE OF SCRATCH MARKS /ABRASIONS ON THE INSTRUMENT MAIN TUBE IS TYPICALLY ATTRIBUTED TO MISUSE. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE THAT THE INSTRUMENT WAS FOUND TO HAVE INSULATION DAMAGE ON THE CONDUCTOR WIRE, EXPOSING THE INTERNAL WIRES. THE DAMAGE WAS LOCATED AT THE DISTAL END AT THE BIPOLAR YAW PULLEY. NO MATERIAL WAS MISSING AND NO THERMAL DAMAGE WAS OBSERVED. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT WAS ALSO FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. THE ROOT CAUSE OF FRAYED - DISTAL INSTRUMENT GRIP CABLES IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE INSTRUMENT LOG FOR THE MARYLAND BIPOLAR FORCEPS (PART# 471172-16 / LOT# K10210823 0227 ) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON 08-MAR-2022 VIA SYSTEM SERIAL# (B)(4). THERE WERE 8 USES REMAINING AFTER THIS LAST USAGE. SEE ATTACHMENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE MARYLAND BIPOLAR FORCEPS 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 DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE HAD DEEP SCRATCHES WHICH COULD NOT BE STERILIZED ANYMORE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE REPORTED WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116903 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 K10210823 0227 00886874119792

    Patients

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