BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING KLINTMALM LIVER TRANSPLANT CLAMP

    MDR report key: 1613128 · Received February 18, 2010

    Report

    Report Number
    1044475-2010-00011
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    January 20, 2010
    Report Date
    January 21, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED FOR EVALUATION. THE RESULTS OF THE DEVICE SAMPLE EVALUATION AND INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: TWO SIZE CLAMPS WERE USED IN SURGERY. THE CLAMPS DID NOT CLOSE UNIFORMLY OR COMPLETELY, THEREFORE ALLOWED BLEEDING TO OCCUR. THIS CAUSED THE SURGERY TO BE PROLONGED SINCE EXTRA TIME HAD TO BE TAKEN TO STOP THE BLEEDING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING KLINTMALM LIVER TRANSPLANT CLAMP KLINTMALM LIVER TRANSPLANT CLAMP GDJ TELEFLEX MEDICAL NA 009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention