BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND GSP.FORCEPS FEN.5/310MM HF.CON.

    MDR report key: 5032881 · Received August 21, 2015

    Report

    Report Number
    2916714-2015-00732
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 12, 2015
    Report Date
    December 30, 2015
    Manufacturer
    AESCULAP, INC.
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510(K): K001330 / K003608. US REPORTING AGENT NOTIFIED ON: (B)(4) 2015. MANUFACTURING SITE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURES NOTED ON RECEIVED PRODUCT: CERAMIC DISPLAYS SEVERAL BREAKS, CONNECTION ROD IS BENT, THRUST IS BENT, HEAVY SIGNS OF WEAR AND TEAR, ESPECIALLY THE SERRATION IN THE JAW, SCRATCHES ON SURFACE, JAW PARTS NOT PARALLEL, THE OUTER TUBE IS CRACKED IN SEVERAL PLACES. THE INSTRUMENT WAS ANALYZED BY MICROSCOPE. THE POINTS OF THE CERAMIC BREAKAGE EXHIBIT NO UNUSUAL STRUCTURAL CONDITIONS, NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FIND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLE USER RELATED. BOTH INSTRUMENTS ARE IN A VERY BAD CONDITION. ACCORDING TO IFU, THIS KIND OF INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY. THE BENDED CONNECTION ROD AND BENDED THRUST ARE MOST LIKELY CAUSED BY A INCORRECT ASSEMBLY. PROBABLY THE CERAMIC BREAKAGES ARE CAUSED BY A MECHANICAL OVERLOAD SITUATION OR A DROP. DUE TO THE CERAMIC BREAKAGES, THE BENDED CONNECTION ROD AND BENDED THRUST, THE MECHANICAL FUNCTION NO LONGER WORKS. MOST LIKELY THE SCRATCHES ON THE SURFACE AND THE WORN SERRATION IS CAUSED BY THE MECHANICAL CLEANING. CORRECTIVE/PREVENTIVE ACTION IS NOT NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). USED DURING LAPAROSCOPY; INSTRUMENT INITIALLY FUNCTIONED PROPERLY, AND THEN NO LONGER COAGULATED. THE DEVICE WAS REPLACED AND THE SECOND DEVICE PRODUCED AN ELECTRICAL ARC INTRA-ABDOMINALLY; RISK OF BURN TO NEARBY ORGANS. OPERATION TIME WAS EXTENDED. COMPONENTS THAT MAKE UP REPORTED DEVICE (PM408R): PM973R/INSULATED OUT TUBE 5/5MM 310MM; PM438R/JAW INS.BIP.MARYLAND DISS.FEN. 5/310MM; PM450R/HANDLE FOR BIPOLAR INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554762 MARYLAND GSP.FORCEPS FEN.5/310MM HF.CON. GEI AESCULAP, INC. PM408R

    Patients

    Seq Age Sex Outcome Treatment
    1