BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO ADSON TISS FCPS 1X2

    MDR report key: 8671622 · Received June 5, 2019

    Report

    Report Number
    2523190-2019-00076
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Report Date
    May 10, 2019
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED . LOT NUMBER / SERIAL NUMBER NOT RECEIVED TO PERFORM DHR REVIEW. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED. THE REPORTED COMPLAINT IS UNCONFIRMED. DEVICE IDENTIFIER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 17-2500 MICRO ADSON TISSUE FORCEPS LOST ITS ¿TEETH¿. THE DEVICE WAS IN CONTACT WITH THE PATIENT, BUT NO INJURY NOTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466112 MICRO ADSON TISS FCPS 1X2 M5 - GENERAL SURGERY GEN INTEGRA YORK, PA INC. 901955

    Patients

    Seq Age Sex Outcome Treatment
    1