BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6367536 · Received March 1, 2017

    Report

    Report Number
    9610773-2017-00026
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    PMA / PMN Number
    PK790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION SINCE IT WAS REPORTEDLY DISCARDED BY THE USER FACILITY. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, 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 NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION, SINCE IT WAS REPORTEDLY DISCARDED BY THE USER FACILITY. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. IN ADDITION, A MANUFACTURING AND QUALITY CONTROL REVIEW COULD NOT BE PERFORMED, SINCE BASIC DATA OF ARTICLE IDENTIFICATION (LOT NUMBER) ARE MISSING. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS, BUT THE REPORTED PHENOMENON WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HF RESECTION ELECTRODE AND THERE WAS NO ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150855 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12° HF-RESECTION ELECTRODES GCP OLYMPUS WINTER & IBE GMBH A22201A

    Patients

    Seq Age Sex Outcome Treatment
    1