BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEIBINGER FIBEROPTIC CABLE ACCEPTAB ROTARY TURRET F DIV ADAPTERS 01-03731/36

    MDR report key: 7184620 · Received January 11, 2018

    Report

    Report Number
    0008010177-2018-00003
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 13, 2017
    Report Date
    July 17, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRX
    PMA / PMN Number
    K874911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CONFIRMATION OF THE REPORTED EVENT WAS NOT POSSIBLE BECAUSE THE DEVICE WAS NOT RETURNED TO STRYKER (B)(4) AND NO MORE RETRIEVABLE. IT WAS REPORTED THAT ¿WHILE USING THE TROCAR CHEEK RETRACTOR WITH LIGHT SOURCE, THE LIGHT SOURCE CORD GOT HOT AND BURNED THE PATIENTS LIP¿. THE PRODUCT WAS LOST DURING RETURN SHIPMENT AND WAS NO MORE RETRIEVABLE. THEREFORE NO THOROUGH PRODUCT INSPECTION COULD BE PERFORMED. THE RELATED INSTRUCTION FOR USE OF THE FIBEROPTIC CABLE AS WELL AS THE RELATED OPERATION AND SERVICE MANUALS OF THE POTENTIALLY USED COMPETITOR LIGHT SOURCES (HOSPITAL USES ONLY TWO DIFFERENT TYPES) WERE REVIEWED. IT WAS FOUND THAT EACH OPERATION AND SERVICE MANUAL STATES SEVERAL WARNINGS AND CAUTIONS REGARDING THERMAL BURNS, HOT CABLE END FITTINGS AS WELL AS THE USE OF FIBERS. SUMMARIZING THE INFORMATION IT CAN BE EXCLUDED THAT THE ROOT CAUSE FOR THE COMPLAINT WAS PRODUCT RELATED. BECAUSE THE POWER OF ONE OF THE COMPETITOR¿S LIGHT SOURCES WAS INITIALLY MOST LIKELY SET ON A TOO HIGH LEVEL THE FIBER OPTIC CABLE END HEATED UP. AS IT IS CLEARLY MENTIONED IN THE COMPETITORS OPERATION AND SERVICE MANUALS THAT ¿USE ONLY FIBER OPTIC LIGHT GUIDE CABLES WITH THE CORRECT PROXIMAL FITTING FOR YOUR TURRET AND APPROVED AND TESTED FOR COMPATIBILITY WITH HIGH INTENSITY XENON LAMPS OF 300W OR HIGHER¿ THE ISSUE CAN BE ATTRIBUTED TO A USER RELATED HANDLING ISSUE. THE APPLICATION OF LEIBINGER FIBER OPTIC CABLES IN COMBINATION WITH ONE OF THE COMPETITOR¿S LIGHT SOURCES IS NOT FORBIDDEN, BUT THE USER HAVE TO USE LOW INTENSITY AS THE LIGHT SOURCES ARE DESIGNED AND THOUGHT TO BE USED WITH PREMIUM FIBER OPTIC CABLES IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE AND PREVENT DAMAGE TO THE FIBERS. BASED ON STATISTICAL EVALUATION THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND / OR PREVENTIVE ACTION IS DEEMED NECESSARY AT THIS MOMENT. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. IF THE PRODUCT WILL BE RETURNED AT A LATER DATE AN APPROPRIATE INVESTIGATION WILL BE PERFORMED, THE COMPLAINT RE-OPENED AND THE RESULT(S) REVISED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A PATIENTS LIP WAS BURNED BY A LIGHT SOURCE UTILIZED ON A TROCAR DURING A CASE AT THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A PATIENTS LIP WAS BURNED BY A LIGHT SOURCE UTILIZED ON A TROCAR DURING A CASE AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25248 LEIBINGER FIBEROPTIC CABLE ACCEPTAB ROTARY TURRET F DIV ADAPTERS 01-03731/36 INSTRUMENT HRX STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1