BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 6013476 · Received October 10, 2016

    Report

    Report Number
    3011137372-2016-00286
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 20, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DHR FOR THE INSTRUMENT IN QUESTION, WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS MANUFACTURED AT THE TECOMET, INC. (B)(4) FACILITY AS PART OF A (B)(4) PC. LOT IN APRIL OF 2015. THE RETURNED INSTRUMENT WAS EVALUATED AND FOUND THAT THE JAWS ARE ALIGNED WITH EACH OTHER AND THE TIP SET AS RECEIVED IS CORRECT PER PRINT SPECS. FURTHER EVALUATION SHOWED THAT THIS INSTRUMENT PICKS UP, RETAINS, CLOSES AND RELEASES CLIPS BOTH WITH AND WITHOUT THE USE OF SILASTIC TEST TUBING AS REQUIRED OF ITS FUNCTION. WE ARE UNABLE TO VALIDATE THE ALLEGED COMPLAINT SINCE WE ARE UNABLE TO DUPLICATE THE ALLEGED ISSUE. PARTS WERE 100% VISUALLY INSPECTED AND TESTED AT THE TECOMET, (B)(4) FACILITY BEFORE INSTRUMENTS WERE SENT TO CUSTOMER. NO IRREGULARITIES WERE FOUND AND OR REPORTED AT THE TIME OF INSPECTION AND ASSEMBLY OF THE PRODUCT AS THIS IS A STANDARDIZED PROCESS FOR ALL INSTRUMENTS MANUFACTURED AT THIS FACILITY. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE JAW OF THE APPLIER WAS NOT IN LINE WHICH CAUSED THE CLIP TO FALL OFF THE APPLIER; NO CLIPS FELL INTO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS GOOD.

    Description of Event or Problem · 1

    THE JAW OF THE APPLIER WAS NOT IN LINE WHICH CAUSED THE CLIP TO FALL OFF THE APPLIER; NO CLIPS FELL INTO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665982 HOL ML 5MM ENDO APPLIER APPLIER,SURGICAL, CLIP GDO TELEFLEX MEDICAL 06B1498896

    Patients

    Seq Age Sex Outcome Treatment
    1