BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 6156089 · Received December 8, 2016

    Report

    Report Number
    3011137372-2016-00345
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 24, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (B)(4) AS PART OF A (B)(4) LOT IN OCTOBER OF 2015. SINCE THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION WE ARE UNABLE TO VALIDATE THIS COMPLAINT OR DETERMINE ROOT CAUSE. ALL INSTRUMENTS ARE THOROUGHLY INSPECTED AND FUNCTION TESTED AT TIME OF MANUFACTURE. 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

    A CLIP REMAINED STUCK IN THE JAWS. THE PHYSICIAN USED ANOTHER APPLIER AND SUTURE TO REMOVE THE LIGATED PART OF THE ARTERY AND THE FIRST APPLIER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    A CLIP REMAINED STUCK IN THE JAWS. THE PHYSICIAN USED ANOTHER APPLIER AND SUTURE TO REMOVE THE LIGATED PART OF THE ARTERY AND THE FIRST APPLIER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807093 HOL ML 5MM ENDO APPLIER APPLIER,SURGICAL, CLIP GDO TELEFLEX MEDICAL 06C1515966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention