BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM

    MDR report key: 4674027 · Received April 6, 2015

    Report

    Report Number
    2916714-2015-00295
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510(K): K093075/K130596. OUTWARD VISUAL INSPECTION: THE INSTRUMENT ARRIVED CLEAN AND DECONTAMINATED IN THE ORIGINAL CARDBOARD BOX. THERE ARE NO MECHANICAL DAMAGES OR MISSING PARTS. ANALYSIS: THE INSTRUMENT PRESENTS IN A PROPER CONDITION. THE MECHANICS, CLAMPING MECHANISM AND THE ARTICULATION, SEEMED TO WORK WELL. BOTH INSULATION TONGUES IN THE YAW HAVE BURN MARKS, ONE SLIGHTLY, THE OTHER HEAVY. ELECTRICAL INSPECTION: EACH CIRCUIT WAS MEASURED SEPARATELY. ONE OF THE CIRCUITS WORKED WELL (RESISTANCE AT CLOSED YAW > 1 M-OHM), THE SECOND CIRCUIT SHOWED A RESISTANCE LOWER THAN 10 OHM. THAT LEADS TO THE "SHORT" MESSAGE OF THE GENERATOR. SEALING TEST OVER WET GAUZE: SEALING TEST OVER WET GAUZE WITH (B)(4). "REGRASP- SHORT". CONCLUSION: THE COMPLAINT (B)(4) EXHIBITS FOLLOWING DEFECTS: SHORT, CAUSED BY BURNED/DAMAGED INSULATION. ROOT CAUSE FOR DAMAGE IS NOT CLEAR.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INSUFFICIENT SEALING. SURGICAL DELAY GREATER THAN 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225833 CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM SEAL AND CUT INSTRUMENT GEI AESCULAP AG & CO KG PL730SU S787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other