BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-URETHROSCOPE-SHEATH

    MDR report key: 1372035 · Received February 18, 2009

    Report

    Report Number
    9611102-2009-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    June 1, 2008
    Report Date
    February 12, 2009
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FBO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYSTOSCOPE SHAFT HAS THE BATCH IDENTIFICATION NUMBER M911290 AND WAS PRODUCED IN FEBRUARY 2003. NO OTHER IDENTIFICATIONS ARE EVIDENT AND THIS MEANS THAT NO SERVICE OPERATIONS HAVE BEEN CARRIED OUT AT (B)(4) SINCE THE SHAFT WAS PURCHASED. THE DISTALLY SOLDERED REINFORCEMENT SHAFT BECAME COMPLETELY DETACHED FROM THE HARD-SOLDER JOINT. MICROSCOPY EXAMINATION OF THE SITE OF THE JOINT SHOWS PROPER DIFFUSION OF THE HARD SOLDER AT THE DISTAL SHAFT TUBE AND THIS GUARANTEED A DURABLE STRENGTH OVER MANY YEARS. THE SOLDER SURFACES ARE COVERED WITH SOME BROWNISH DEPOSITS, ARE DISCOLORED AND PARTLY OXIDIZED. IN VIEW OF THE MANY YEARS OF SERVICE AND THE AGE OF THE INSTRUMENT, WE ATTRIBUTE THE LOOSENING OF THE HARD-SOLDER JOINT TO A LONG-TERM CHEMICAL PROCESS. THIS PROCESS IS FAVORED BY THE FOLLOWING FACTORS: LARGE NUMBER OF CASES WHICH RESULT IN AN INCREASE IN THE NUMBER OF REPROCESSING CYCLES, USAGE TIMES OF ABOVE-AVERAGE DURATION, MORE CONTAMINANTS AND OPERATING RESIDUES. IT IS REASONABLE TO ASSUME THAT THESE FACTORS TRIGGER UNAVOIDABLE WEAR AND TEAR PROCESS IN MEDICAL INSTRUMENTS AND CAN ULTIMATELY LEAD TO THE DESTRUCTION OF SUCH JOINTS. IN ORDER TO BE IN A POSITION TO IDENTIFY INCIPIENT DAMAGE, IT IS EXTREMELY IMPORTANT TO EXAMINE INSTRUMENTS APPROPRIATELY BEFORE AND AFTER USE AND TO BE VIGILANT IN DETECTING MISSING PARTS AND AS NECESSARY SEGREGATE THESE PARTS. EXPLANATIONS ON THIS ISSUE ARE GIVEN IN OUR OPERATING MANUALS.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE HOSPITAL THAT A MALE PT HAD A RIGID CYSTOSCOPY IN (B)(6) 2008. IN (B)(6) 2008, HE HAD A FURTHER CYSTOSCOPY WITH A FLEXIBLE CYSTOSCOPE WHEN A FOREIGN BODY WAS SEEN. HE WAS EXAMINED AGAIN IN (B)(6) 2008 AT A DIFFERENT HOSPITAL AND THE OBJECT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYSTO-URETHROSCOPE-SHEATH CYSTO-URETHROSCOPE-SHEATH FBO RICHARD WOLF GMBH 8650,044 M911290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention