BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 8603122 · Received May 13, 2019

    Report

    Report Number
    8603122
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 21, 2019
    Report Date
    May 8, 2019
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO USE 5MM JUSTRIGHT STAPLER DURING THE SURGICAL PROCEDURE; HOWEVER, THE INSTRUMENT MADE A CRACKING NOISE WHEN CLAMPED AND WOULD NOT FIRE ANY STAPLES. SURGEON WAS ABLE TO REMOVE THE INSTRUMENT FROM PATIENT'S TISSUE. SURGEON STATED THE TISSUE WAS CRUSHED WHERE HE HAD ATTEMPTED TO CLAMP DOWN AND FIRE WITH THE INSTRUMENT. AT THIS POINT, NO DAMAGE TO THE TISSUE WAS NOTED. THE INSTRUMENT WAS THEN REMOVED FROM THE SURGICAL FIELD AND TAGGED. SURGEON ATTEMPTED TO USE THE JUSTRIGHT STAPLER TO TRANSECT THE DIVERTICULUM, BUT WAS UNABLE DUE TO MALFUNCTION. SURGEON THEREFORE PERFORMED A BOWEL RESECTION. PT DID WELL POST-OPERATIVELY AND WAS DISCHARGED TO HOME IN STABLE CONDITION. DEFECTIVE PRODUCT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396417 JUSTRIGHT 5MM STAPLER STAPLE, IMPLANTABLE GDW JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75BI1201

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA Other| R