BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1080514 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00438
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/11/2008. EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER'S COMPLAINT. IT WAS FOUND THAT THE GREEN CABLE HAS A CRACK AND IS RUSTING. TO CORRECT THE COMPLAINT THE ANALYSIS TECHNICIAN ADDED HEAT SHRINK TO THE GREEN AND BLUE CABLES. THEY ALSO FOUND THE SAFETY LATCH WAS BENT AND THE E-CLIP WAS DAMAGED DURING DISASSEMBLY AND REPLACED BOTH PARTS AS A CORRECTION. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED TOP FRAME, POSITIONING SPRING, POSITIONING SPRING SCREW AND ROTATION KNOB. ALSO REPLACED PORT SHAFT, COIL PIN, SPADE ASSEMBLY AND SPUR GEAR. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE, NO SERVICE HISTORY REVIEW CAN BE DONE. 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 UNK GREEN CABLE ERRORS WERE OCCURRING DURING A BREAST BIOPSY. THE CASE WAS ABORTED WITHOUT ANY CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES NONE KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE