BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLUS AUTOMATIC GRASPE

    MDR report key: 15754128 · Received November 7, 2022

    Report

    Report Number
    MW5113128
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 22, 2022
    Report Date
    November 3, 2022
    Manufacturer
    ENDOPLUS INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A LAP CHOLE(LAPAROSCOPIC CHOLECYSTECTOMY), AN ATRAUMATIC GRASPER TIP BROKE WHILE IN USE. ALL VISIBLE PARTS OF THE GRASPER WERE REMOVED FROM THE PATIENT. UPON INSPECTION FROM THE SCRUB TECH, SHE NOTICED A VERY SMALL PIECE/BOLT THAT MIGHT HOLD THE JAWS TOGETHER MIGHT BE MISSING FROM THE GRASPER. WE WERE UNSURE DUE TO HOW SMALL THIS PIECE/BOLT MIGHT ACTUALLY BE. THE SURGICAL TEAM AND CHARGE NURSE WERE ALERTED TO THE SITUATION. CSR WAS NOTIFIED AND ONE OF THEIR TECHS CAME UP TO INSPECT THE INSTRUMENT TO SEE IF THEY NOTICED A PIECE WAS MISSING. WE WERE UNABLE TO DETERMINE FOR SURE IF AN ACTUAL PIECE WAS MISSING FROM THE GRASPER, BUT IF ONE WAS, IT WOULD BE SO SMALL THAT IT WOULD BE UNTRACEABLE. AFTER DISCUSSION WITH STAFF AND SURGICAL TEAM, AN X-RAY WAS NOT TAKEN DUE TO HOW SMALL THE PIECE IS IF THERE WAS A PIECE MISSING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511774 ENDOPLUS AUTOMATIC GRASPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ENDOPLUS INC. 5333

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male