BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX HOLSTER

    MDR report key: 1082926 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00684
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K033700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE FLEX CIRCUIT WAS CAUSING A CONSTANT L3-010 ERROR PER THE CUSTOMER COMPLAINT. TO CORRECT THIS ISSUE, THE ANALYSIS SITE REPLACED THE FLEX CIRCUIT. ADDITIONALLY THE TRANSLATIONAL DRIVE SHAFT WAS DAMAGED AND WAS REPLACED, AND THE BOTTOM MOTOR MOUNT WAS DAMAGED DURING DISASSEMBLY AND WAS REPLACED. 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 ERROR CODE OF L3-010 IS NOT GOING AWAY FROM THE LCD SCREEN PRIOR TO A BREAST BIOPSY. THE CUSTOMER INSERTED ANOTHER HOLSTER AND THE FOOT SWITCH PEDDLE WORKED WITHOUT ERROR. THE CUSTOMER WAS ABLE TO FINISH THE PT'S BIOPSY USING ANOTHER BIOPSY DEVICE. THERE WAS NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME EX HOLSTER KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE