BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK TAKE-A-APART 5MM ENDO APPLIER

    MDR report key: 2002286 · Received January 26, 2011

    Report

    Report Number
    1044475-2011-00011
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 12, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO MANUFACTURER AT THIS TIME. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SUBMITTED WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A PROSTECTOMY SURGERY THE LITTLE SCREW IN THE JAW OF THE APPLIER WAS LOST. INTENSIVE WASHING OF THE ABDOMINAL CAVITY WAS PERFORMED WITHOUT LOCATION OF THE SCREW. ALL FLUIDS COLLECTED DURING THE SURGERY WERE ALSO FILTERED AND THE SCREW WAS NOT LOCATED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLOK TAKE-A-APART 5MM ENDO APPLIER TAKE-A-APART APPLIER FZP TELEFLEX MEDICAL NA 080041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK