BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISIGRIP VEIN STRIPPER

    MDR report key: 843018 · Received April 6, 2007

    Report

    Report Number
    1220948-2007-00003
    Event Type
    Other
    Date Received
    April 6, 2007
    Date of Event
    March 9, 2007
    Report Date
    April 6, 2007
    Manufacturer
    *
    Product Code
    GAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INCIDENT WAS REPORTED BECAUSE AN EXTRA PROCEDURE WAS COMPLETED TO REMOVE THE NOSEPIECE THAT HAD DETACHED FROM THE VEIN STRIPPER. THE EVALUATION OF THE COMPLAINT DEVICE DISPLAYED THE NOSEPIECE BLADES WERE SEVERELY BENT AND THERE WAS DRIED UP TISSUE TANGLED IN BETWEEN THE BLADES. THE EVALUATION DISPLAYED THE DEVICE SEEMED TO BE USED IN A TORTUROUS VESSEL WHICH MAY HAVE HAD THROMBUS. THIS IS AN INITIAL REPORT. WE HAVE ASKED THE PHYSICIAN FOR FURTHER INFORMATION ON THE CONDITION OF THE VESSEL AND HOW THE DEVICE WAS USED. WITHOUT THIS INFORMATION WE ARE NOT ABLE TO MAKE A CONCLUSION AT THIS TIME. WE WILL SEND A FOLLOW-UP REPORT WITH FURTHER INFORMATION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE NOSEPIECE OF THE INVISIGRIP VEIN STRIPPER BROKE OFF IN THE PATIENT. AN EXTRA INCISION WAS MADE TO REMOVE THE NOSE PIECE. THE PATIENT 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 * Required Intervention