BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1152726 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03733
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE AN MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND PER THE SERVICE MANUAL PERFORMED SERVICE AND FUNCTIONAL TESTS AND FOUND THE HOLSTER'S GREEN CABLE HAD A SPLIT IN IT, CAUSING A LOUD GRINDING NOISE. TO CORRECT THE COMPLAINT, THE ANALYSIS SITE REPAIRED THE GREEN CABLE BY ADDING HEAT SHRINK TO THE GREEN AND BLUE CABLES. THE ANALYSIS SITE ALSO REPLACED THE PORT SHAFT DUE TO IT WAS BENT, THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING THE UNIT PASSED ALL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSLTER IS MAKING A LOUD GRINDING NOISE WHILE TAKING A SAMPLE DURING A BREAST BIOPSY. ANOTHER HOLSTER WAS USED TO COMPLETE THE CASE WITH NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES KNW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE