BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE

    MDR report key: 6334837 · Received February 16, 2017

    Report

    Report Number
    9610773-2017-00008
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 24, 2017
    Report Date
    July 11, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    PMA / PMN Number
    PK931763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THE VISUAL INSPECTION CONFIRMED THAT THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE IS BROKEN OFF. OLYMPUS AMERICA INC. ("OAI") IS IMPLEMENTING A REMOVAL ACTION OF SPECIFIED LOT NUMBERS OF THE MONOPOLAR HF RESECTION ELECTRODES A22201C AND WA22037C. THE ELECTRODES ARE USED FOR ENDOSCOPIC DIAGNOSIS AND TREATMENT IN UROLOGICAL AND GYNECOLOGICAL APPLICATIONS. OAI HAS INITIATED THIS REMOVAL ACTION AFTER RECEIVING AN INCREASED NUMBER OF COMPLAINTS REGARDING LOOP WIRES BREAKING AT THE DISTAL END OF THE REFERENCED ELECTRODES. INVESTIGATIONS HAVE CONFIRMED THAT LOOP WIRES CAN BREAK DURING THE INTENDED USE OF THE ELECTRODES. AS A RESULT, A FRAGMENT MAY FALL INSIDE THE PATIENT AND WILL NEED TO BE RETRIEVED. RETRIEVAL OF THE FRAGMENT COULD PROLONG THE PROCEDURE AND, UNDER CERTAIN CIRCUMSTANCES, COULD REQUIRE ADDITIONAL SURGICAL TREATMENT. THE INVESTIGATION REVEALED THAT THE LOOP WIRES OF THE AFFECTED ELECTRODES WERE DAMAGED DURING PRODUCTION. THE CAUSE OF THIS DAMAGE IS DEFECTIVE MANUFACTURING EQUIPMENT. THE DAMAGED LOOP WIRES CANNOT BE DETECTED BY VISUAL INSPECTION. THERE HAS BEEN NO REPORT TO DATE OF AN ADVERSE EVENT OR PATIENT INJURY. HOWEVER, IN AN EFFORT TO PREVENT A POTENTIAL RISK TO PATIENT HEALTH, OAI IS UNDERTAKING THIS ACTION TO REMOVE THE AFFECTED LOT NUMBERS. OAI'S CORRECTION NUMBER ACCORDING TO 21 CFR 806.10 (C) (1): 2429304-4/18/2017-044R.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. HOWEVER, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED YET SINCE THE EVALUATION/INVESTIGATION IS STILL ONGOING. AS SOON AS THE INVESTIGATION RESULTS AND FINAL EVALUATION ARE AVAILABLE, THIS REPORT WILL BE UPDATED. THE EVALUATION IS STILL ONGOING.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TOWARDS THE END OF A TRANSURETHRAL RESECTION OF THE BLADDER TUMOR (TURBT) PROCEDURE, IT WAS NOTICED THAT THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE HAD BROKEN OFF. IT IS UNKNOWN IF ANY DEVICE FRAGMENT FELL INSIDE THE PATIENT'S BLADDER. HOWEVER, IT WAS ASSUMED THAT IT WAS FLUSHED OUT WITH IRRIGATION FLUID SINCE NO FOREIGN OBJECTS WERE DISCOVERED INSIDE THE BLADDER. THERE WAS NO ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117809 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE HF-RESECTION ELECTRODES FAS OLYMPUS WINTER & IBE GMBH A22201C 16210P03L001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED VALLEYLAB ELECTROSURGICAL GENERATOR