BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCLIP LIGATING CLIP APPLIERS, TITANIUM CLI

    MDR report key: 1022688 · Received April 1, 2008

    Report

    Report Number
    3003898360-2008-00012
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Report Date
    February 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WILL MONITOR THIS ISSUE THROUGH TRENDING. THE DEVICE HAS BEEN RECEIVED AND CURRENTLY BEING EVALUATED. THE DEVICE HAS BENE RETURNED FOR EVALUATION; HOWEVER; INVESTIGATION IS IN-PROGRESS. ADDITIONAL INFORMATION: DEVICE IS LABELED AS STERILE, SINGLE USE, DISPOSABLE. THE APPLIER CONTAINS 20 STERILE CLIPS. BASED ON THE COMPLAINT DESCRIPTION, IT CANNOT BE RULED OUT THE END USER HAD REUSED THE APPLIER; "DEVICE DID NOT LOAD PROPERLY WHEN IT STILL CONTAINED 5 CLIPS AND WAS REPLACED WITH A NEW APPLIER." THE FEEDER WHICH ALLEGEDLY BROKE IS MADE OF POLYCARBONATE; PER THE MSD IT DOES NOT CONTAIN ANY REPORTABLE HAZARDOUS MATERIALS. A FOLLOW UP REPORT WILL BE FORWARDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR A TOTAL CYSTECTOMY A DEVICE DID NOT LOAD PROPERLY WHEN IT STILL CONTAINED 5 CLIPS AND WAS REPLACED WITH A NEW APPLIER. THE DEFECTIVE APPLIER WAS TEST FIRED OVER THE INSTRUMENT TABLE. CUSTOMER ALLEGES A BLACK SEGMENT OF THE FEEDER FELL OFF. PATIENT WAS X-RAYED WITH NO INDICATION OF A SEGMENT FOUND IN THE BODY. CUSTOMER ALLEGES THEY COLLECTED THE REMAINING PIECES OF THE FEEDER AND FOUND THERE WERE PIECES MISSING. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCLIP LIGATING CLIP APPLIERS, TITANIUM CLI AUTOMATIC LIGATING CLIP APPLIERS GDO TELEFLEX MEDICAL T1268646

    Patients

    Seq Age Sex Outcome Treatment
    1