BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6367329 · Received March 1, 2017

    Report

    Report Number
    9610773-2017-00023
    Event Type
    Malfunction
    Date Received
    March 1, 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

    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 HAS 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 DEVICE IS 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 AT UNKNOWN DATE, THE LOOP WIRE AT THE DISTAL END OF AT LEAST ONE HF RESECTION ELECTRODE BROKE OFF AND FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HF RESECTION ELECTRODE AND THERE WAS NO ADVERSE EVENT OR PATIENT INJURY. THIS IS REPORT 5 OUT OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150582 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE HF-RESECTION ELECTRODES FAS OLYMPUS WINTER & IBE GMBH A22201C P16X0003

    Patients

    Seq Age Sex Outcome Treatment
    1