BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE 550

    MDR report key: 827324 · Received March 12, 2007

    Report

    Report Number
    2914019-2005-00103
    Event Type
    Injury
    Date Received
    March 12, 2007
    Date of Event
    September 1, 2005
    Report Date
    March 12, 2007
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS REQUESTED THE TREATMENT PARAMETERS UTILIZED AT THE TIME OF THE REPORTED PROBLEM WITH THE FIBER; THE TREATMENT PARAMETERS WERE NOT PROVIDED BY THE CUSTOMER FOR THE LUMENIS INVESTIGATION. LUMENIS REQUESTED THE LOT NUMBER OF THE FIBER, AND THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER. THE ASSOCIATED POWERSUITE 100W DEVICE HAD BEEN SERVICED BY LUMENIS ON 08/17/2005 AT THE REQUEST OF THE CUSTOMER AND NO FINDINGS WERE REPORTED BY THE LUMENIS CUSTOMER ENGINEER THAT WOULD RELATE TO THE REPORTED PROBLEM WITH THE SURGICAL FIBER. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION COULD BE DRAWN REGARDING ROOT CAUSE. LUMENIS REPLACED THE FIBER UNDER RMA (CF42150, BOSTON COMPLAINT # 662726). 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.

    Description of Event or Problem · 1

    THE SCRUB TECHNICIAN WAS HOLDING THE FIBER DURING THE HOLAP CASE AND THE FIBER BROKE; THE TECHNICIAN'S HAND REC'D A SECOND DEGREE BURN. THERE WAS NO PT INJURY. THE TECHNICIAN WAS TREATED IN THE E.R. (NO PRESCRIPTION MEDICATION WAS GIVEN). ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE. PER THE CUSTOMER, THE TECHNICIAN WAS TO BE OFF WORK FOR 3 WEEKS AND WAS SCHEDULED TO RETURN TO WORK IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 550 FIBERS GEX LUMENIS LTD. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R NONE REPORTED