BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1121892 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01160
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/13/2008. EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MFR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE BLUE CABLE WAS WORN AND CAUSING ERRORS PER THE CUSTOMER COMPLAINT. TO CORRECT THE COMPLAINT, THE ANALYSIS SITE REPLACED THE BLUE CABLE. THE SITE WAS UNABLE TO DUPLICATE THE CUSTOMER COMPLAINT OF UNUSUAL NOISE. THE SAFETY LATCH WAS REPLACED DUE TO IT WAS BENT, THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. PER THE SERVICE MANUAL, SERVICE TESTS WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE SERVICE PROCESS, HEAT SHRINK WAS ADDED TO THE GREEN AND BLUE CABLES. 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 DURING A BREAST BIOPSY PROCEDURE, A CLICKING NOISE WAS HEARD AND THE PROBE JAMMED THEN AN UNSPECIFIED ERROR CODE WAS RECEIVED. THE PROBE WAS CHANGED AND WORKED PROPERLY. WHEN THE HOLSTER WAS TESTED, IT WAS NOTICED THAT A BLUE CABLE ERROR CODE WAS RECEIVED. THERE WERE NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE