BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSAPULSE VPW-110V

    MDR report key: 827469 · Received March 6, 2007

    Report

    Report Number
    2914019-2004-00031
    Event Type
    Other
    Date Received
    March 6, 2007
    Date of Event
    April 15, 2004
    Report Date
    March 6, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE EVALUATED THE VERSAPULSE VPW DEVICE ON 5/04/2004, AT THE REQUEST OF THE CUSTOMER. PER THE LUMENIS CUSTOMER ENGINEER CE, NO PROBLEMS WERE FOUND WITH THE 532 NM WAVELENGTH. PER THE CE, THERE WAS LOW OUTPUT POWER ON THE 755 NM WAVELENGTH (WHICH WAS NOT USED FOR THE PATIENT'S TREATMENT). THE CE PERFORMED A ROUTINE PERIODIC MAINTENANCE. THIS COMPLAINT WAS EVALUATED BY BOTH A LUMENIS CLINICAL (PHYSICIAN) EXPERT AND A LUMENIS ENGINEER, WHO CONCLUDED THAT THE DEPTH OF PENETRATION OF THE VERSAPULSE VPW 532 NM BEAM IS TOO SHALLOW TO AFFECT THE HAIR FOLLICLES. THE PHYSICIAN CONSULTANT STATED, "THERE IS ABSOLUTELY NO WAY TO DAMAGE HAIR FOLLICLES WITH THE VERSAPULSE. THERE MAY BE TRANSIENT SINGING OF THE HAIR FOLLICLES, BUT THERE IS NO DESTRUCTION OF HAIR WITH THE VERSAPULSE. ALSO, THERE IS NO EVIDENCE IN THE LITERATURE OF ANY DESTRUCTION OF HAIR FOLLICLES WITH THE LONG PULSE 532 NM LASER. THE PULSE DURATION IS INAPPROPRIATE." FOLLOWING EVALUATION OF THE PATIENT'S COMPLAINT BY A LUMENIS ENGINEER AND PHYSICIAN CONSULTANT, LUMENIS DETERMINED THAT THE PATIENT'S COMPLAINT OF HAIR LOSS IS NOT RELATED TO THE LUMENIS DEVICE. NO FURTHER CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    FOLLOWING TREATMENT TO THE FOREHEAD WITH 532 NM (LONG PULSE GREEN) TO STIMULATE COLLAGEN GROWTH, A MALE PATIENT CLAIMED HE HAD LOST HIS HAIR AT THE HAIRLINE AND EYEBROWS, AND THE PATIENT ATTRIBUTED THIS TO THE VERSAPULSE LASER. THE PATIENT SUBSEQUENTLY OBTAINED HAIR REPLACEMENT TREATMENT TO THESE AREAS. PER THE PHYSICIAN, THE 532 NM WAVELENGTHS HAS TOO SHALLOW A PENETRATION TO CAUSE THIS TYPE OF COMPLAINT. THE PATIENT ALSO CLAIMED, THAT THE LASER TREATMENT HAS GREYED HIS HAIR. PER THE PHYSICIAN, GREY HAIR DOES NOT RESPOND TO LASER HAIR REMOVAL (DUE TO LACK OF CHROMOPHORE). PER THE LUMENIS INVESTIGATION, THE CLAIM THAT THE HAIR WAS GREYED, SEEMS TO CONTRADICT THE PATIENT'S CLAIM OF HAIR LOSS. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER DATED JULY 25, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE VPW-110V SURGICAL LASERS GEX LUMENIS, INC. 110 V *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other ANTI-PSYCHOTIC MEDICATION