BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6398509 · Received March 13, 2017

    Report

    Report Number
    9610773-2017-00034
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    March 6, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE HF RESECTION ELECTRODES FROM THE SAME MODEL AND LOT WERE RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THE VISUAL INSPECTION CONFIRMED THAT THE LOOP WIRES AT THE DISTAL END OF THE HF RESECTION ELECTRODES ARE BROKEN OFF. FURTHERMORE, THE SHAFTS OF THE HF RESECTION ELECTRODES ARE BENT. OLYMPUS AMERICA INC. ("OAI") IS IMPLEMENTING A REMOVAL ACTION OF SPECIFIED LOT NUMBERS OF THE MONOPOLAR HF RESECTION ELECTRODES (B)(4). 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 DEVICES HAVE NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICES ARE RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE LOOP WIRES OF 13 HF RESECTION ELECTRODES FROM TWO DIFFERENT LOTS (16173P03L001; 16223P03L001) BROKE OFF AND FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED BY UNKNOWN APPROACH. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HF RESECTION ELECTRODE AND THERE WAS NO ADVERSE EVENT OR PATIENT INJURY. THIS IS REPORT 1 OUT OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183232 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE HF-RESECTION ELECTRODES FAS OLYMPUS WINTER & IBE GMBH A22201C 16173P03L001

    Patients

    Seq Age Sex Outcome Treatment
    1