BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAW INS.BIP.MARYLAND DISS.FEN.5/310MM

    MDR report key: 6062041 · Received October 27, 2016

    Report

    Report Number
    2916714-2016-00937
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    August 4, 2016
    Report Date
    October 31, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K001330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. ADDITIONAL INFORMATION: D2. PRODUCT CODE WAS PREVIOUSLY HGI. G5. 510K CODE WAS PREVIOUSLY K003608.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT DURING AN OPERATION THE CERAMIC PART OF THE JAW BROKE. THE MISSING PARTS WERE COLLECTED, BUT IT IS NOT CLEAR IF ALL PARTS WERE COLLECTED. IT WAS REPORTED IN THE INITIAL REPORT THAT THE PRODUCT WAS PURCHASED IN OCTOBER OF 2004, AND EXCEEDS ITS RECOMMENDED USAGE.

    Additional Manufacturer Narrative · 1

    THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A (B)(6). WE MADE A VISUAL INSPECTION OF THE JAW PARTS. HERE WE FOUND A VISIBLY DAMAGED BLUE CERAMIC WITH A CRACK AND BROKEN OFF AREAS. FURTHERMORE, WE FOUND A BROKEN GREY CERAMIC AND A BROKEN OFF AREA. ADDITIONALLY WE FOUND THAT THE JAW IS NOT LATERALLY OVERLAPPING. WE MADE A VISUAL INSPECTION OF THE BROKEN OFF FRAGMENT. HERE WE FOUND DARK DISCOLORATION. THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. WE ASSUME A MECHANICAL OVERLOAD SITUATION AS THE CAUSAL FACTOR AND THIS WILL RESULT IN THE JAW NOT OVERLAPPING. THERE IS THE POSSIBILITY OF TORSION OR HIGH LEVERAGE WITH THE INSTRUMENT. ACCORDING TO THE QUALITY STANDARD A PRODUCTION ERROR OR A MATERIAL DEFECT CAN BE EXCLUDED. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710768 JAW INS.BIP.MARYLAND DISS.FEN.5/310MM ENDOSCOPY GEI AESCULAP AG PM438R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other