BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSES 200 D/F/L

    MDR report key: 10498185 · Received September 6, 2020

    Report

    Report Number
    3004135191-2020-00061
    Event Type
    Malfunction
    Date Received
    September 6, 2020
    Date of Event
    June 9, 2020
    Report Date
    September 4, 2020
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109143170
    Removal / Correction Number
    4600210000-2020-8015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS OPENED INITIALLY ON 6/17/2020 AND WAS TREATED AS NON-SAFETY. THEN, LATER ON 8/3/2020 LUMENIS RECEIVED A MEDWATCH REPORT FROM THE FDA (# (B)(4)) DESCRIBING A PRODUCT PROBLEM AT DIXIE REGIONAL MEDICAL CENTER IN JUNE OF 2020 WITH TWO (2) MOSES 200 MICRON D/F/L FIBERS (LOT #50140120, REF # AC-10030100). THE COMPLAINT DESCRIPTION IS AS FOLLOWS; "DURING A LEFT URETEROSCOPY, TWO MOSES D/F/L MICRON LASER FIBERS (LOT #50140120, REF # AC-10030100) FAILED WITH BOTH THE NEW (# 816197) AND OLD (# 234563) HOLMIUM LASERS. THE ISSUE CAUSES A 20-MINUTE DELAY IN PATIENT CARE IN THE OR. THE LASER WORKED NORMALLY WHEN USING THE 365-MICRON LASER FIBER." THERE WAS NO PATIENT INJURY OR COMPLICATION, JUST THE INCONVENIENCE OF A DELAYED PROCEDURE WHILE THE TWO FIBERS WERE BEING REPLACED WITH A THIRD THAT WORKED NORMALLY. THREE COMPLAINTS WERE OPENED BY THE CUSTOMER FOR THIS EVENT (2 FOR THE 2 FIBERS THAT FAILED AND 1 PRESUMABLY FOR THE EVENT ITSELF). THESE ARE (B)(4). AFTER SEVERAL ATTEMPTS LUMENIS WAS ABLE TO RECOVER THE FAILED FIBERS AND PERFORMED A FAILURE ANALYSIS ON THEM. THE FAILURE OBSERVATION WAS; FIBER IS BROKEN APPROXIMATELY 4" FROM DISTAL TIP. DISTAL END IS BURNT / MELTED AND SMA ALSO SHOWS BURN MARKS. THE ROOT CAUSE CONCLUSION WAS; OPERATIONAL CONTEXT - THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE LUMENIS DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED. THIS EVENT HAS BEEN DETERMINED TO BE A FIBER MALFUNCTION, HOWEVER THE DECISION TREE HAS DETERMINED THAT THE EVENT IS NOT REPORTABLE. A LUMENIS CLINICAL EXPERT HAS ALSO PROVIDE HIS COMMENTS; THESE FIBERS ARE USED IN SURGERIES REGULARLY, AND IT IS THE COMMON PRACTICE TO HAVE ADDITIONAL FIBERS IN THE OR, LIKE IN THIS CASE, TO COMPLETE THE CASE WITHOUT ADDITIONAL ANESTHESIA OR MEDICAL INTERVENTION. THUS, THIS EVENT IS NOT REPORTABLE. HIS COMMENTS SUPPORT THE DECISION TREE CONCLUSION OF NOT REPORTABLE. AS A RESPONSE THE FDA MEDWATCH REPORT WE HAVE RECEIVED LUMENIS WILL FILE MDR # 3004135191-2020-00061 FOR THIS PARTICULAR MOSES 200 FIBER REFERENCED IN (B)(4).

    Description of Event or Problem · 1

    DURING A LEFT URETEROSCOPY, TWO MOSES D/F/L MICRON LASER FIBERS (LOT #50140120, REF # AC-10030100) FAILED WITH BOTH THE NEW (# 816197) AND OLD (# 234563) HOLMIUM LASERS. THE ISSUE CAUSES A 20-MINUTE DELAY IN PATIENT CARE IN THE OR. THE LASER WORKED NORMALLY WHEN USING THE 365-MICRON LASER FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962779 MOSES 200 D/F/L POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE: GEX GEX LUMENIS LTD MOSES 200 D/F/L 50140120 07290109143170

    Patients

    Seq Age Sex Outcome Treatment
    1