BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6055887 · Received October 25, 2016

    Report

    Report Number
    2916714-2016-00882
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 23, 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 IS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY SURGERY, A JAW BROKE FROM THE DEVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYECE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE JAW PARTS. HERE WE FOUND A VISIBLY DAMAGED BLUE CERAMIC WITH A BROKEN OFF AREA. FURTHERMORE WE FOUND UNKNOWN DEPOSITS. WE MADE A VISUAL INSPECTION OF THE BROKEN OFF FRAGMENT. HERE WE FOUND GREY DISCOLORATION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: WE ASSUME A MECHANICAL OVERLOAD SITUATION AS THE CAUSAL FACTOR. THERE IS THE POSSIBLITY 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
    705070 JAW INS.BIP.MARYLAND DISS.FEN.5/310MM ENDOSCOPY GEI AESCULAP AG PM438R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other