BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISIGRIP VEIN STRIPPER

    MDR report key: 865422 · Received June 15, 2007

    Report

    Report Number
    1220948-2007-00003_2
    Event Type
    Other
    Date Received
    June 15, 2007
    Date of Event
    March 9, 2007
    Report Date
    May 16, 2007
    Product Code
    GAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT STATED WE WILL ASK THE PHYSICIAN FOR FURTHER INFO ON THE CONDITION OF THE VESSEL OR ANY OTHER INFO HE MAY BE ABLE TO PROVIDE. THE PHYSICIAN STATED THE VESSEL WAS NOT TORTUROUS. HE HAS USED THIS PRODUCT MANY TIMES WITHOUT FAILURE. THE ROOT CAUSE OF THE TIP DETACHING IS UNKNOWN. THE OPERATORS WERE MADE AWARE OF THIS COMPLAINT AND RETRAINING WAS CONDUCTED AS A PREVENTIVE MEASURE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE NOSEPIECE OF THE INVISIGRIP VEIN STRIPPER BROKE OFF IN THE PT. AN EXTRA INCISION WAS MADE TO REMOVE THE NOSE PIECE. THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISIGRIP VEIN STRIPPER VEIN STRIPPER GAJ 1500-05 IVS1037

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention