BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE ENDO HERNIA

    MDR report key: 9733196 · Received February 20, 2020

    Report

    Report Number
    2647580-2020-00647
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 24, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    UDI-DI
    10884521070592
    PMA / PMN Number
    K912097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE E-PIECE WAS PARTIALLY DISENGAGED FROM THE DEVICE ON ONE SIDE. THERE WAS EVIDENCE OF WELD ON THE DEVICE. ONE TACK WAS RECEIVED JAMMED IN THE E PIECE. THE SINGLE USE LOADING UNIT (SULU) WAS RECEIVED PRELOADED ON THE INSTRUMENT WITH ONE TACK REMAINING. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE E-PIECE WAS PARTIALLY DISENGAGED FROM THE DEVICE ON ONE SIDE. THERE WAS EVIDENCE OF WELD ON THE DEVICE. ONE TACK WAS RECEIVED JAMMED IN THE E PIECE. THE SULU WAS RECEIVED PRELOADED ON THE INSTRUMENT WITH ONE TACK REMAINING. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR AS A RESULT OF EXCESSIVE MANIPULATION OF THE DEVICE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS FOUND TO BE DUE TO THE DEVICE NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FUR THER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN CLOSING THE MESENTERIC DEFECT, WHEN THE FIRST STAPLE WAS FIRED IT CAME OUT AN ANGLE AND STUCK IN THE DEVICE. IT WAS REMOVED WITH AN ARTERY CLIP THEN THE STAPLER WAS FIRED AGAIN ON THE OUTSIDE OF BODY AND WAS FOUND THAT ALL THE FIRED STAPLES WERE MALFORMED. A NEW STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195786 MULTIFIRE ENDO HERNIA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO 174025 P9J1171Y 10884521070592

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR