BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2311468 · Received October 10, 2011

    Report

    Report Number
    8010168-2011-00001
    Event Type
    Malfunction
    Date Received
    October 10, 2011
    Manufacturer
    GEOMED MEDIZIN-TECHNIK GMBH & CO.
    Product Code
    GWG
    PMA / PMN Number
    K052745
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROCEDURE WAS ABORTED WITHOUT DIRECT IMPACT TO THE PATIENT. HOWEVER, IT IS TO BE ASSUMED THAT THE PROCEDURE WILL HAVE TO BE REPEATED AND COMPLETED AT A FUTURE DATE. THE MANUFACTURER WILL PERSEVERE IN HIS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION AND OUTCOMES. THE COMMON DEVICE NAME IS ENDOSCOPE HOLDER. THE PRODUCT CODES ASSIGNED BY FDA DURING 510(K) REVIEW WERE GWG AND GCJ. THE NUMBERS (B)(4) ARE WRONGLY IDENTIFIED AS SERIAL NUMBERS ON THE USER FACILITY REPORT. THEY ARE CATALOG NUMBERS. ONLY THE DEVICE IDENTIFIED BY CATALOG # CA340-30-01 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE # C1310-50-01 HAS NOT BEEN RETURNED BY THE USER FACILITY. IT IS A CLAMP DEVICE THAT IS USED TO FASTEN THE ENDOSCOPE HOLDER ARM TO THE OPERATING TABLE. AN INITIAL EVALUATION OF THE FRACTURED DEVICE HAS BEEN PERFORMED. THE INITIAL EVALUATION MENTIONED IN THE PRECEDING PARAGRAPH IDENTIFIES SEVERAL FACTORS THAT MAY HAVE INDIVIDUALLY OR COLLECTIVELY CAUSED OR CONTRIBUTED TO CAUSING THE EVENT. EVALUATION OF THESE FACTORS IS IN PROGRESS. ONCE THIS EVALUATION IS COMPLETE, A DECISION CAN BE MADE REGARDING THE REMEDIAL OR CORRECTIVE ACTION THAT IS TO BE TAKEN. MATERIAL EXAMINATION: RESULT: THE MATERIAL-COMPOSITION OF THE BALL CORRESPONDS TO THE GRADE (B)(4). THE MATERIAL-CONDITION, CONCERNING THE PROPERTIES ADJUSTED DURING MELTING AND FORMING, ARE CONSIDERED AS NORMAL. THE HARDENING WAS DONE IN THE MIDDLE AUSTENITIZATION RANGE. THE SUBSEQUENT COOLING WAS NOT FAST ENOUGH TO PREVENT A PRECIPITATION OF CARBIDES ALONG THE GRAIN-BOUNDARIES. HENCE, THERE IS A MARTENSITIC STRUCTURE WITH CLEARLY VISIBLE PRECIPITATIONS ALONG THE GRAIN-BOUNDARIES. THE TEMPERING-PROCESS ADJUSTED A TYPICAL HARDNESS OF (B)(4). THE SECTION OF THE FRACTURE-AREA SHOWS A MOSTLY INTERCRYSTALLINE-CRACKING. PARTLY, THERE ARE GAPING GRAIN-BOUNDARIES. THE FRACTURE-FLANKS ARE FREE OF OXIDES OR DECARBURIZATION. BECAUSE OF THE FRACTURE-APPEARANCE WITH ITS INTERCRYSTALLINE-CRACKING, THE GAPING GRAIN-BOUNDARIES AND THE RED RESIDUES, THE EXAMINER IS OF THE OPINION, THAT THE BRIDGE OF THE BALL FAILED DUE TO AN INTERCRYSTALLINE STRESS-CORROSION CRACKING. IF THERE HAS BEEN AN AGGRESSIVE MEDIA ONTO THE SURFACE OF THE MATERIAL, OR IF TOO HIGH WORKING PRESSURES WERE APPLIED, CANNOT BE STATED, BUT THE USED MATERIAL, DUE TO ITS PRECIPITATION ALONG THE CARBIDES, IS PRONE TO SUCH A FAILURE MODE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GWG GEOMED MEDIZIN-TECHNIK GMBH & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1