BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 12486748 · Received September 17, 2021

    Report

    Report Number
    2955842-2021-11139
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 16, 2021
    Report Date
    August 19, 2021
    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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) WAS ABLE TO CONFIRM AND REPRODUCE THE REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT'S CONDUCTOR WIRE WAS OBSERVED TO HAVE DAMAGE TO THE INSULATION. A TEAR IN THE INSULATION MEASURED APPROXIMATELY 0.020" X 0.031" AND THERE WAS NO MATERIAL MISSING. THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST. THE ROOT CAUSE OF THE FAILURE WAS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE INSTRUMENT LOG OF THE FENESTRATED BIPOLAR FORCEPS (PART # 471205-17 / LOT # N10210531-0008) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK3352. THE PROCEDURE ON THIS DATE WAS THE 4TH USE OF THE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WERE AVAILABLE FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE FAILURE ANALYSIS FOUND THE CONDUCTOR WIRE TO HAVE DAMAGED INSULATION WITH A PASSED ELECTRICAL CONTINUITY TEST. WHILE THERE WAS NO HARM OR INJURY TO A PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A DAMAGED CABLE. SPECIFICALLY, THE BLACK COATING WAS COMING OFF AND A FRAYED SILVER CABLE UNDERNEATH WAS EXPOSED. THIS WAS FOUND DURING THE NORMAL CLEANING PROCESS IN STERILE PROCESSING AND THERE WAS NO PATIENT WAS INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR (THE INITIAL REPORTER) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 31-AUG-2021. THE INSTRUMENT ARRIVED AT STERILE PROCESSING ALREADY DAMAGED. SHE WAS NOT CERTAIN IF THIS DAMAGE WAS DISCOVERED PRIOR TO STARTING A PROCEDURE, DURING A PROCEDURE, OR DURING TRANSPORTATION TO STERILE PROCESSING. SHE DID STATE THAT IF IT WAS USED DURING A PROCEDURE, THERE HAVE BEEN NO RECENT COMPLAINTS ABOUT ARCING SO THERE WOULD HAVE BEEN NO INJURY TO THE PATIENT. NO PATIENT INFORMATION WAS PROVIDED BECAUSE SHE COULD NOT BE CERTAIN IF IT WAS RELATED TO A PROCEDURE. NO FURTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389327 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 N10210531 0008 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES