BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15612716 · Received October 15, 2022

    Report

    Report Number
    2955842-2022-14618
    Event Type
    Malfunction
    Date Received
    October 15, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 15, 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 Location
    JA
    Reporter Occupation
    003

    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 REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF DAMAGED CONDUCTOR WIRE INSULATION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATION. THE INSULATION DID NOT EXHIBIT THERMAL DAMAGE. THE INSULATION MATERIAL WAS LIFTED, HOWEVER, NO PIECES WERE MISSING. THE CONDUCTOR WIRE WAS SLIGHTLY EXPOSED, HOWEVER NO WIRES WERE PHYSICALLY DAMAGED. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED AND THE INSTRUMENT PASSED. THE ROOT CAUSE OF THE DAMAGED CONDUCTOR INSULATION IS ATTRIBUTE TO MISHANDLING/MISUSE, COMMONLY CAUSED BY COLLISION WITH ANOTHER INSTRUMENT OR SHARP OBJECT. A REVIEW OF THE DEVICE LOGS FOR THE MARYLAND BIPOLAR FORCEPS INSTRUMENT (PART# 471172-16 / LOT/SERIAL# (B)(4) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6)2022 . A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAE. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THERE DOES NOT APPEAR TO BE ANY DAMAGE TO THE CONDUCTOR WIRE OR ANY EXPOSED WIRE. THIS COMPLAINT IS BEING REPORTED BASED ON 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 DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A CRACK IN THE INSULATION COATING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITY WAS FOUND. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR TOOL DURING THE PROCEDURE. THE REPORTED ISSUE WAS FOUND AFTER REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742974 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 K10211206 0169 00886874119792

    Patients

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