BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, SMR, 5/PK

    MDR report key: 9369665 · Received November 25, 2019

    Report

    Report Number
    2951238-2019-01200
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 31, 2019
    Report Date
    April 22, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF A DEVICE HISTORY RECORD (DHR) REVIEW AND UPDATE TO SECTION H6. DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED BASED ON OLYMPUS SURGICAL TECHNOLOGIES AMERICA (OSTA) SHARED DHR LOCATION. THERE WERE NO DEVIATION NOTED IN THE DHR. UNIT WAS BUILT PER OSTA PROCESS AND OPERATION SEQUENCES WERE LISTED PROPERLY. THERE WAS NO SCRAP ACTIVITY. PRE ASSEMBLY, POST ASSEMBLY AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE PASSED ALL FUNCTIONAL TESTS. DUE TO NO DEVICE RETURN, A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE BLADE WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION AS IT WAS DISCARDED AFTER THE PROCEDURE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING A THERAPEUTIC SINUPLASTY/TURBINATE REDUCTION PROCEDURE, THE HEAT SHRINK SEPARATED FROM THE BLADE AT THE DISTAL END. NO UNEXPECTED BLEEDING REPORTED. NO PIECES OF PLASTIC FELL INTO PATIENT TO SURGEONS KNOWLEDGE. PROCEDURE WAS COMPLETED WITH THE SAME BLADE. THE PATIENT DID NOT NEED A LONGER STAY OR ADDITIONAL PROCEDURES. THE PROCEDURE WAS NOT DELAYED. THERE WAS NO PATIENT INJURY REPORTED. IN ADDITION, THE BLADE WAS INSPECTED BEFORE THE CASE AND NO ABNORMALITIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164383 BIPOLAR BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, SMR, 5/PK BIPOLAR BLADE, 2MM, GEI GYRUS ACMI, INC BB2000SA CA853907

    Patients

    Seq Age Sex Outcome Treatment
    1