BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMTOME ST HOLSTER/CABLES

    MDR report key: 1834587 · Received December 11, 2007

    Report

    Report Number
    1527736-2007-08414
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    November 29, 2007
    Report Date
    November 29, 2007
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - THE UNIT WAS RETURNED TO THE ANALYSIS SITE DUE TO UNIT GAVE THE ERROR CODE OF L3-017. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT OF L3-017 ERROR CODE AND TO CORRECT THE COMPLAINT THE SITE REPLACED THE PORT SHAFT AND COIL PIN DUE TO THE SHAFT WAS BENT, THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL 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 THERE WERE NO ERROR CODES UPON THE CUTTER LOCKING UP ON RETURN OF THE CUTTER IN THE POSITIONING MODE. TROUBLESHOOTING GAVE THE ERROR CODE OF L3-017. ONE DEVICE TO BE EVALUATED FOR GREEN CABLE DAMAGE. THE CUSTOMER WAS ABLE TO USE ANOTHER DEVICE TO COMPLETE THE BIOPSY. THERE WERE NO PT CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE