BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    MDR report key: 1800602 · Received August 3, 2010

    Report

    Report Number
    2647580-2010-00676
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: THE GRASPER WOULD NOT ARTICULATE BACK TO THE STRAIGHT POSITION IN ORDER TO GET OUT OF THE ACCESS PORT AFTER IT WAS USED. THE DOCTOR SPENT A FEW MINUTES TRYING TO STRAIGHTEN IT. HE FINALLY DID AND REMOVED IT FROM THE PATIENT. AT THAT POINT HE NOTICED THE BLACK WRAP THAT COVERS THE ARTICULATING PORTION OF THE TIP WAS ALL CHEWED UP. THERE WAS NO TISSUE DAMAGE OR PATIENT INJURY REPORTED. NO ADDITIONAL BLOOD LOSS AND NO NEED TO REPLACE INSTRUMENT AS THE CASE WAS OVER. THIS EVENT DID NOT RESULT IN EXTENSION IN OPERATIVE TIME MORE THAN 30 MINUTES. THERE WAS NO REPORT OF PARTS FALLING INTO THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK DISPOSABLE SURGICAL ACCESSORY GCJ USSC PUERTO RICO P0C0089

    Patients

    Seq Age Sex Outcome Treatment
    1