BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCAPS

    MDR report key: 1038783 · Received May 6, 2008

    Report

    Report Number
    2951580-2008-00032
    Event Type
    Other
    Date Received
    May 6, 2008
    Date of Event
    December 1, 2007
    Report Date
    April 30, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K072865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE INCIDENT WAS NOT PROVIDED. AN APPROX DATE IS PROVIDED. THE DEVICE WAS REPORTED AS DISCARDED FOLLOWING THE PROCEDURE. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD FOR LOT 9122170-A WAS PERFORMED. THE LOT MET ALL DEVICE SPECS. THERE ARE NO OTHER SIMILAR REPORTS FOR THIS LOT. AWAITING FURTHER DETAILS REGARDING USE OF THE DEVICE DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ON APRIL 9, 2008, A CLINICAL INCIDENT INVOLVING A MICROCAPS ARTHROWAND WAS REPORTED TO ARTHROCARE CORP. FOLLOWING A CAPSULAR SHRINKAGE PROCEDURE OF THE LEFT WRIST, THE PT WAS REPORTED TO DEVELOPED ULNAR NERVE PALSY. IN 2008, THE PHYSICIAN REPORTED THE PT HAS NUMBNESS IN HER RING AND LITTLE FINGERS, WEAKNESS OF THE SMALL MUSCLES OF THE HAND, NUMBNESS OVER THE DORSUM OF THE ULNAR SIDE OF THE HAND AND HAS HAD PAIN WHICH IS REPORTED TO BE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCAPS ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA 9122170-A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other