BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSAPULSE VPW-220V

    MDR report key: 104744 · Received July 8, 1997

    Report

    Report Number
    2914019-1997-00021
    Event Type
    Other
    Date Received
    July 8, 1997
    Date of Event
    June 4, 1997
    Report Date
    June 9, 1997
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3- SIMILAR DEVICE HAS BEEN EVALUATED. FURTHER INVESTIGATION HAS REVEALED THE FOLLOWING: THE CHILL TIP THAT WAS USED BY THE DOCTOR WHO HAD PUBLISHED THE RECOMMENDED PARAMETERS WAS EVALUATED. THE CHILL TIP DEVICE IS USED WITH THE VERSAPULSE VPW WHEN TREATING LEG VEINS. THE EVAL REVEALED LOW TRANSMISSION. AS A RESULT OF THE LOW TRANSMISSION THE FLUENCES INDICATED ON THE LASER WERE APPROXIMATELY 20% HIGHER THAN THOSE DELIVERED TO THE SKIN. ALL REPLACEMENT CHILLED TIPS HAVE NOW BEEN SENT TO THE CUSTOMERS. ALL CUSTOMERS HAVING CHILLED TIPS WERE GIVEN AN UPDATED PAPER DESCRIBING CLINICAL GUIDELINES FOR ADJUSTING TREATMENT PARAMETERS. H.6- NEW CODES REFLECT EVAL OF THE SIMILAR DEVICE AS STATED ABOVE.

    Description of Event or Problem · 1

    PT HAD SEVERE BLISTERING AFTER LEG VEIN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE VPW-220V SURGICAL LASER GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention