BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEX LASER INSTRUMENT, SURGICAL

    MDR report key: 8386493 · Received March 4, 2019

    Report

    Report Number
    1820334-2019-00486
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    May 2, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND TRENDS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: IMPROPER HANDLING MAY AFFECT THE LIFE OF ANY PARTICULAR FIBER NEVER SUBJECT FIBEROPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THE CAUSE COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 28MAR2019: IT WAS REPORTED, THEY WERE PREPARING FOR AN UNKNOWN PROCEDURE. THE LASER FIBER WAS SCREWED INTO THE LASER MACHINE, BUT IT DID NOT FEEL LIKE IT SCREWED IN CORRECTLY. THEY ATTEMPTED TO REMOVE THE FIBER, BUT WERE UNABLE TO. A BACK UP LASER MACHINE WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # - K124030. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LASER FIBER BROKE AT THE CONNECTOR. THE CUSTOMER CANNOT REMOVE THE OLD FIBER FROM THE SYSTEM. INFORMATION OBTAINED FROM THE SERVICE REPORT: THE FIBER IS BROKEN AT THE CONNECTOR. REMOVED BROKEN FIBER. CHECKED THE LASER- OK. ADDITIONAL INFORMATION REGARDING THIS EVENT, PATIENT, AND PRODUCT HAS BEEN REQUESTED. HOWEVER, AT THE TIME OF THIS REPORT NO FURTHER INFORMATION HAS BEEN FORTHCOMING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180280 GEX LASER INSTRUMENT, SURGICAL GEX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RHAPSODY H30, SERIAL NUMBER, (B)(4)