BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX HOLSTER

    MDR report key: 1250803 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03368
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 6, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THAT EXCESSIVE BODY FLUIDS CAUSED THE TRANSVERSE DRIVE SHAFT AND ITS SURROUNDING COMPONENTS TO BE NON FUNCTIONAL. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE TRANSVERSE DRIVE SHAFT AND THE BUSHING. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCEDURES. 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 WHILE SETTING UP FOR A BREAST BIOPSY WITH THE EX HOLSTER, A MESSAGE WAS RECEIVED THAT THE UNIT WOULD NOT RECOGNIZE THE HOLSTER. THERE WAS NO PT CONSEQUENCE REPORTED. CASE WAS COMPLETED USING THE CORE NEEDLE. EX HOLSTER BEING RETURNED FOR REPAIR.

    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 CONTROL MODULE| PROBE