BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROBLATOR 30 ARTHROWAND

    MDR report key: 632391 · Received August 31, 2005

    Report

    Report Number
    2951580-2005-00013
    Event Type
    Other
    Date Received
    August 31, 2005
    Date of Event
    April 15, 2005
    Report Date
    August 16, 2005
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005, A CLINICAL INCIDENT INVOLVING A MICROBLATOR 30 ARTHROWAND WAS REPORTED TO ARTHROCARE CORPORATION. DURING AN ARTHROSCOPIC PROCEDURE OF THE WRIST, THE PATIENT'S JOINT CAPSULE WAS REPORTED TO HAVE BEEN CUT WITH THE DEVICE. THE PATIENT WAS REPORTED TO HAVE LOST THE ABILITY TO MOVE THE MID AND MEDICINAL FINGERS. THE PATIENT WAS ALSO REPORTED TO NOT HAVE RESPONDED WELL TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROBLATOR 30 ARTHROWAND ELECTROSURGICAL DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other