BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4963934 · Received July 30, 2015

    Report

    Report Number
    2916714-2015-00638
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    June 23, 2016
    Manufacturer
    AESCULAP, INC.
    Product Code
    GEI
    PMA / PMN Number
    K001330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K): K003608. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED. ONE OF THE JAW PARTS IS BROKEN OFF. THE INSTRUMENT WAS ANALYZED BY MICROSCOPE. THE POINT OF BREAKAGE SHOWS A LIGHT FLUSH RUST DUE TO THE LONG STORAGE TIME, BUT NO UNUSUAL STRUCTURAL CONDITIONS SUCH AS PORES,INCLUSIONS OR FOREIGN BODIES COULD BE FOUND. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE INSTRUMENT IS VALIDATED FOR A MAXIMUM OF 50 REPROCESSING CYCLES. ACCORDING TO THE SURGEON, THE INSTRUMENT WAS SHOWING SIGNS OF WEAR AND TEAR, IT IS NOT COMPREHENSIBLE WHY IT STILL WAS USED. IT IS EXPRESSLY POINTED OUT IN THE IFU THAT SUCH INSTRUMENTS MUST NO LONGER BE USED. CORRECTIVE/PREVENTIVE ACTION IS NOT REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). A PIECE OF THE JAW BROKE INTO THE PATIENT. THIS PIECE IS STILL INSIDE THE PATIENT AS DOCTOR WAS UNABLE TO RETRIEVE. DOCTOR IS MONITORING THE PATIENT. HE BELIEVES THE INSTRUMENT; IN PARTICULAR THE INSERT, WAS SHOWING SIGNS OF WEAR AND TEAR. HOSPITAL CLAIMS THEY WERE UNAWARE OF THE REQUIRED LIMITED USES OF 30-40 TIMES ONLY FOR THIS DEVICE, AND ADMITTED THEY HAD NOT BEEN MONITORING HOW MANY CASES IT HAD BEEN USED FOR. THE DELAY IN SURGERY WAS LESS THAN 15 MINUTES AND THE PATIENT IS BEING MONITORED AND DISCHARGED FROM HOSPITAL. OPERATION WAS ON THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498695 JAW INS. BIP. MARYLAND DISS.FCPS 5/310MM FORCEP GEI AESCULAP, INC. PM431R

    Patients

    Seq Age Sex Outcome Treatment
    1