BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE EZ 200¿ FIBER

    MDR report key: 9150441 · Received October 3, 2019

    Report

    Report Number
    3004135191-2019-00113
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 3, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    00729010914019
    PMA / PMN Number
    K170121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE REASONABLE FOLLOW UP FOR ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT; NO ADDITIONAL INFORMATION WAS PROVIDED. LUMENIS CANNOT RULE OUT THAT THE FIBER TIP HAD BROKEN OFF IN THE PATIENT'S ANATOMY, AND IN AN ABUNDANCE OF CAUTION LUMENIS IS REPORTING THIS EVENT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. A REVIEW OF SYSTEM RISK FILES REVEALED THE FOLLOWING THREE RISKS OF FIBERS BREAKING INSIDE BODY: RISK #1 ((B)(4)) TRIGGERED BY "USER DAMAGES FIBER EXTERNAL SURFACE DURING OPERATION" HAS THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE, EQUIPMENT DAMAGE, PATIENT/USER/STAFF INJURY. RISK #2 ((B)(4)) TRIGGERED BY "FIBER IS DAMAGED DURING SHIPMENT" HAS THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE, EQUIPMENT DAMAGE, PATIENT/USER/STAFF INJURY. RISK #3 ((B)(4)) TRIGGERED BY "USER ERROR (E.G. EXCESS ENERGY) CAUSES MECHANICAL DAMAGE TO FIBER" HAS THE POTENTIAL TO LEAD TO PROLONGED PROCEDURE, EQUIPMENT DAMAGE, PATIENT/USER/STAFF INJURY. IN EACH OF THE AFOREMENTIONED; THE RISK HAS BEEN QUANTIFIED AND FOUND TO BE NEGLIGIBLY SMALL, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. NO CORRECTIVE ACTION OR REMEDIAL ACTIONS WERE DEEMED NECESSARY. SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER FOR VISUAL INSPECTION ON 25-SEP-2019. INITIAL FINDINGS REVEALED THAT THE "TIP OF FIBER IS BROKEN WITHOUT BURNS OR MELTING". LUMENIS QUALITY ASSURANCE HAD DETERMINED 'OPERATIONAL CONTEXT' TO BE THE ROOT CAUSE OF THE REPORTED TIP BREAK; 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. LUMENIS IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THIS FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP ((B)(4)) AND PER POST MARKETING SURVEILLANCE PROCEDURE ((B)(4)).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING AN URETEROSCOPY PROCEDURE IN WHICH A SLIMLINE EZ 200 FIBER WAS BEING UTILIZED, THE TIP OF THE FIBER BROKE OFF IN THE PATIENT'S URETER. THE TIP WAS REMOVED WITH A BASKET AND AFTER REPLACING THE FIBER WITH A NEW ONE, THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE FACILITY USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE CASE WITH NO PATIENT COMPLICATIONS. NO REPORT OF INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943777 SLIMLINE EZ 200¿ FIBER POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD. SLIMLINE EZ 200¿ FIBER 34360419 00729010914019

    Patients

    Seq Age Sex Outcome Treatment
    1