BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSAPULSE 2.1 HOLMIUM

    MDR report key: 156441 · Received March 10, 1998

    Report

    Report Number
    2914019-1998-00002
    Event Type
    Other
    Date Received
    March 10, 1998
    Date of Event
    December 22, 1997
    Report Date
    February 10, 1998
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COHERENT ENLISTED THREE DOCTORS TO PERFORM CLINICAL EVALUATIONS. THESE WERE NOT COMPLETED. IT WS NO LONGER NECESSARY TO PURSUE DUE TO THE CONCLUSION IN A WRITTEN ARTICLE BY JOEL M.H. TIECHMAN, PAOLO C. CHAMPION, TIM A. WOLLIN AND JOHN D DENSTED PUBLISHED BY THE JOURNAL OF UROLOGY, DATED 12/1998. (VOL. 160, 2130-2132) "CONCLUSIONS: THERE WERE NO OBVIOUS CYANIDE RELATED COMPLICATIONS FROM HOLMIUM: YAG LITHOTRIPSY OF URIC ACID CALCULI. THESE DATA SUGGEST NO SIGNIFICANT CYANIDE TOXICITY FROM HOLMIUM: YAG LITHOTRIPSY OF URIC ACID CALCULI IN TYPICAL CLINICAL SETTINGS. ANIMAL STUDIES ARE WARRANTED TO CHARACTERIZE THE RISK." AS REPORTED IN INITIAL MEDWATCH; COHERENT HAS HAD NO REPORTED INCIDENCES OF DEATH, SERIOUS ILLNESSES, OR SYSTEMIC OR CENTRAL NERVOUS SYSTEM EVENTS DURING THE CLINICAL INVESTIGATION OF HOLMIUM LASER LITHOTRIPSY UNDER IDE G920082 (OEN OF TWENTY-FIVE PTS HAD A URIS CALCULI). COHERENT HOLMIUN LASERS WERE CLEARED FOR USE OF LITHOTRIPSY IN 5/1994. THERE HAVE BEEN NO REPORTED INCIDENCES OF DEATH, SERIOUS ILLNESSES, OR SYSTEMIC OR CENTRAL NERVOUS SYSTEM EVENTS DURING OF FOLLOWING HOLMIUM LASER LITHOTRIPSY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS GEX COHERENT MEDICAL LASER GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other