BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1831575 · Received September 11, 2010

    Report

    Report Number
    1056128-2010-00058
    Event Type
    Malfunction
    Date Received
    September 11, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ASCENT
    Product Code
    NLM
    PMA / PMN Number
    K062497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO ASCENT FOR EVALUATION. PICTURES OF THE DEVICE AND PACKAGING WERE PROVIDED. EXAMINATION OF THE PICTURES REVEALED THAT THE SUTURE ANCHOR WAS DETACHED AND THAT THE PRONG OF THE ANCHOR HAD FRACTURED. SINCE THE COMPLAINT DEVICE COULD NOT BE EVALUATED A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, HISTORICAL REPORTS OF THE SAME OR SIMILAR ISSUES HAVE TYPICALLY BEEN DETERMINED TO BE A RESULT OF CYCLIC LOADING AND/OR OVERLOAD OF THE SUTURE ANCHOR. ASCENT'S INSTRUCTIONS FOR USE STATE: DO NOT USE EXCESSIVE FORCE. CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE ANCHOR BROKE OFF OF THE TROCAR AND 40 MINUTES WAS SPENT LOOKING FOR THE ANCHOR. THE ANCHOR DID NOT FALL INTO THE PATIENT AND WAS FOUND OUTSIDE THE PATIENT. ADDITIONAL ANESTHESIA WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLM NLM ASCENT H12LP 1172624

    Patients

    Seq Age Sex Outcome Treatment
    1