BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS FOR EASY CLIP 10 MM

    MDR report key: 2364483 · Received December 2, 2011

    Report

    Report Number
    3004082045-2011-00044
    Event Type
    Malfunction
    Date Received
    December 2, 2011
    Date of Event
    December 15, 2009
    Report Date
    December 15, 2009
    Manufacturer
    MEMOMETAL TECHNOLOGIES SA
    Product Code
    HTD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSP CONFIRMED THE BREAKAGE. THE ROOT CAUSE MAY BE DUE TO FATIGUE LIFE CYCLING. AS INSTRUCTED BY (B)(4) ON (B)(4) 2011, MDR REPORTED BY MEMOMETAL TECHNOLOGIES/(B)(4) AS A RESULT OF A RETROSPECTIVE LOOK BACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF MEMOMETAL TECHNOLOGIES BY STRYKER CORP.

    Description of Event or Problem · 1

    THE FORCEPS FOR THE SUPERELASTIQUE STAPLE BROKE. NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCEPS FOR EASY CLIP 10 MM INSTRUMENT HTD MEMOMETAL TECHNOLOGIES SA NA C080403-10-00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability