BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR GRASPER

    MDR report key: 7619911 · Received June 20, 2018

    Report

    Report Number
    7619911
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 29, 2018
    Report Date
    May 31, 2018
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PULLING MESH THROUGH A LAPAROSCOPIC PORT AND THE HUNTER BOWEL GRASPER BROKE WHILE IN THE ABDOMEN. CIRCULATOR CALLED SERVICE COORDINATOR AND THE STRYKER REPRESENTATIVE TO ASSESS THE INSTRUMENT. THE STRYKER REPRESENTATIVE EXAMINED THE GRASPER AND CONFIRMED ALL COMPONENTS WERE ACCOUNTED FOR. NO RISK OF BROKEN PIECES LOST IN ABDOMEN. STRYKER HAS REPORTED THIS PROBLEM TO THE HEADQUARTERS AS THE SAME INSTRUMENT HAS BROKEN RECENTLY IN OTHER PROCEDURES. MANUFACTURER RESPONSE FOR STRYKER HUNTER BOWEL GRASPER, (BRAND NOT PROVIDED) (PER SITE REPORTER). STRYKER HAS NOTED THIS HAPPENED IN OTHER FACILITIES. WE HAD TWO INSTRUMENTS BREAK HERE. THE MANUFACTURER HAS STATED THAT THIS HAS HAPPENED IN OTHER CASES SO THEY CONTACTED THEIR HEADQUARTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462731 MONOPOLAR GRASPER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY 250-080-233

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR