BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE GUIDWIRE

    MDR report key: 11502276 · Received March 17, 2021

    Report

    Report Number
    9681834-2021-00026
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 17, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1. THIS REPORTED EVENT HAS BEEN DEEMED NOT REPORTABLE BASED UPON EVALUATION RESULTS OF THE ACTUAL SAMPLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: REQUESTED, NOT PROVIDED; 0YK PROVIDED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. NAME - REQUESTED, NOT PROVIDED. HEALTH PROFESSIONAL- REQUESTED, NOT PROVIDED. OCCUPATION- REQUESTED, NOT PROVIDED. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REVIEW OF MANUFACTURING RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF NOVEMBER 2020 LOT (0YK) CONFIRMED THERE WAS NO INDICATION OF ANOMALY IN THEM. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SINGLE USE GUIDEWIRE WAS USED PRE-TREATMENT. DURING THE INSERTION OF GUIDEWIRE IN A SCOPE, THEY FOUND THAT COATING ON THE PROXIMAL PART OF THE GUIDEWIRE HAD PEELED OFF BEFORE THE GUIDEWIRE WENT OUT FROM THE DISTAL END OF THE SCOPE. THE PEELING OF COATING WAS OBSERVED IN A PART OF THE PROXIMAL HALF OF THE GUIDEWIRE. DUE TO THE PEELING, THE GUIDEWIRE WAS REPLACED WITH ANOTHER FROM THE SAME CODE AND NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397265 SINGLE USE GUIDWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1