BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12309241 · Received August 11, 2021

    Report

    Report Number
    9610773-2021-00221
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 25, 2020
    Report Date
    August 11, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    14042761036648
    PMA / PMN Number
    K790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE, 12 PCS. PMA/510K: K790071/ K903323/ K951863/ K954488/ K931763/ K931764. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. A DHR REVIEW CANNOT BE PERFORMED SINCE THE LOT NUMBER IS UNKNOWN. HOWEVER, THE MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE LAST 24 MONTHS OF PRODUCTION AND THERE ARE NO NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO WEAR AND TEAR. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING. THE INSTRUCTIONS FOR USE STATE A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED DURING AN APPLICATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS THE RESECTOSCOPE LOOP BROKE INTRAOPERATIVELY DURING USE. THE CUSTOMER REPORTED NO ADVERSE EVENT OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED OF THE CUSTOMER. HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE BROKEN LOOP FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207162 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE HF-RESECTION ELECTRODE GCP OLYMPUS WINTER & IBE GMBH A22201C UNKNOWN 14042761036648

    Patients

    Seq Age Sex Outcome Treatment
    1