BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK TAKEAPART LG 10MM ENDO APPLIER

    MDR report key: 5046212 · Received September 1, 2015

    Report

    Report Number
    3005236665-2015-00013
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    May 28, 2015
    Report Date
    August 4, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HBT
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DHR OF THE LOT SHOWS THAT THE RIGHT MATERIAL AND COMPONENTS WERE USED AND THAT THE INSTRUMENT MEETS ALL SPECIFICATIONS. COMPLAINT INSTRUMENT 544965T, LOT HANDLE 0945321-004, LOT SHAFT 0945400-023 WAS RECEIVED FOR INVESTIGATION. THE SHAFT IS BROKEN OFF THE NUT. IT IS NOT POSSIBLE TO DISASSEMBLE THE INSTRUMENT. APPLIER WILL BE FORWARDED TO THE SUPPLIER FOR FURTHER INVESTIGATION. SUPPLIER REPORTED ON THE 28TH OF SEPTEMBER 2015, THAT THEY RECEIVED INSTRUMENT 544995T, LOT HANDLE (B)(4), AND LOT SHAFT (B)(4), INSERT (B)(4) FOR INVESTIGATION. THE INSTRUMENT HAS NEVER BEEN REPAIRED BEFORE. THE HANDLE WAS DELIVERED IN (B)(4) 2010, THE SHAFT WAS DELIVERED IN (B)(4) 2010 AND THE INSERT WAS DELIVERED IN (B)(4) 2012. THE EVALUATION DISCOVERED THAT THE ROTATING WHEEL IS BROKEN OFF THE SHAFT. IN SPITE OF THE DAMAGE, THE INSTRUMENT WAS WORKING CORRECTLY IN ASSEMBLED CONDITION. THE COMPLAINT ISSUE THAT THE CLIPS ARE FALLING OUT OF THE APPLIER COULD NOT BE CONFIRMED. NO CORRECTIVE ACTION TAKEN IN MANUFACTURING, AS THE FAILURE IS NOT DESIGN OR MATERIAL RELATED.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE LOCKING MECHANISM DOES NOT CLOSE FIRMLY, IN SOME CASES THE CLIP DROPPED FROM THE MECHANISM AND FELL INSIDE THE PATIENT BUT WAS RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE LOCKING MECHANISM DOES NOT CLOSE FIRMLY, IN SOME CASES THE CLIP DROPPED FROM THE MECHANISM AND FELL INSIDE THE PATIENT BUT WAS RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579866 HEMOLOK TAKEAPART LG 10MM ENDO APPLIER APPLIER HBT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1