BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL FIBER

    MDR report key: 851304 · Received May 7, 2007

    Report

    Report Number
    2914019-2003-00020
    Event Type
    Other
    Date Received
    May 7, 2007
    Date of Event
    October 15, 2003
    Report Date
    May 7, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER USED DURING THE PROCEDURE WAS A COHERENT HOLMIUM SURGICAL LASER IDENTIFIED BY THE ENDUSER. THE FIBER USED DURING THE PROCEDURE WAS A SLIMLINE 200 (IDENTIFIED BY THE ENDUSER, WHICH NUMBER DOES NOT CORRESPOND TO A LUMENIS LOT NUMBER). THE SLIMLINE 200 IS A REUSABLE SURGICAL FIBER. AS OF 2007, IT IS NOT KNOWN TO LUMENIS WHETHER THE SUBJECT SLIMLINE 200 FIBER WAS USED PRIOR TO THE PROCEDURE IN QUESTION. PER THE LASER LOG RECORDED BY THE MOBILE LASER PROVIDER, THERE WERE NO EQUIPMENT PROBLEMS DURING THE PROCEDURE. PT ALLEGES THAT THE LASER FIBER FRACTURED AND BURNED A HOLE IN THE SIDE OF THE URETEROSCOPE AND THROUGH THE PT'S URETER. PER THE PHYSICIAN, THE URETER WAS TORN DURING INSERTION OF THE SCOPE, A STANDARD RISK ASSOCIATED WITH THIS PROCEDURE. NO FURTHER CONCLUSION CAN BE DRAWN AT THIS TIME REGARDING ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    PT ALLEGES THAT DURING A LITHOTRIPSY PROCEDURE, THE SLIMLINE 200 LASER FIBER FRACTURED AND BURNED A HOLE IN THE SIDE OF THE URETEROSCOPE AND THROUGH THE PT'S URETER. PER THE PHYSICIAN, THE URETER WAS TORN DURING INSERTION OF THE SCOPE, A STANDARD RISK ASSOCIATED WITH THIS PROCEDURE. PER THE PHYSICIAN, THE FIBERS DID FRACTURE, AND THE PHYSICIAN HAD TO CLEAN THE FRAGMENTS OUT OF THE PT'S BLADDER AND SURROUNDING TISSUE, WHICH CAUSED THE SURGERY TO LAST LONGER THAN THE PHYSICIAN WOULD HAVE LIKED, AND MAY HAVE CAUSED A LARGER ACCUMULATION OF FLUID THAT HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL FIBER HO:YAG/ND:YAG SURGICAL LASER FIBER DELIVERY DEVICE GEX LUMENIS LTD SLIMLINE 200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention NONE REPORTED