BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IGLESIAS WORKING ELEMENT

    MDR report key: 7033895 · Received November 15, 2017

    Report

    Report Number
    2951238-2017-00725
    Event Type
    Injury
    Date Received
    November 15, 2017
    Report Date
    January 19, 2018
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    FBO
    PMA / PMN Number
    PK951972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED DEVICE AND FOUND THE BLOCK ACTUATOR CHARRED AND BURNED AT THE ACTIVE CORD INPUT. A WATER LEAK TEST WAS PERFORMED AND THE DEVICE PASSED THE LEAK TEST. THE ELECTRODE O-RING AND RACK SUPPORT O-RING WAS FOUND INTACT. THE TELESCOPE CHANNEL PASSAGE AND LOCKING MECHANISM WERE TESTED AND INSPECTED WITH NO ANOMALIES FOUND. BASED ON THE EVALUATION FINDINGS, THIS TYPE OF PHENOMENON IS DUE TO FLUIDS INVADING THE CONNECTION BLOCK CAUSING AN ELECTRICAL SHORT TO OCCUR DUE TO THE POOR CONNECTION OF THE ELECTRODE, WORKING ELEMENT AND CABLE. THE INSTRUCTION MANUAL WARNS USERS ¿INSERT THE PK BIPOLAR WORKING ELEMENT WITH ASSEMBLED TELESCOPE AND ELECTRODE INTO THE APPROPRIATE RESECTOSCOPE SHEATH BY ALIGNING THE RED DOTS AND SNAPPING TOGETHER. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS, AND CAUTIONS MAY LEAD TO SERIOUS SURGICAL CONSEQUENCES OR INJURY TO THE PATIENT. MISUSE OF INSTRUMENTS CAN CAUSE INJURY TO THE PATIENT AND COULD HAVE AN ADVERSE EFFECT ON THE PROCEDURE BEING PERFORMED.¿

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS AND IS CURRENTLY PENDING EVALUATION. OLYMPUS IS STILL INVESTIGATING THIS REPORTED EVENT AND HAS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION. THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SURGEON SUSTAINED A BURN TO THE HAND, WHILE OPERATING THE WORKING ELEMENT. THE SURGEON INSPECTED THE INSIDE OF THE WORKING ELEMENT AND NOTED BLACK CHAR WHERE IT HAD BURNT. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED OR IF THE SURGEON WAS MEDICALLY TREATED FOR THE BURN. THERE WAS NO PATIENT INJURY REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812931 IGLESIAS WORKING ELEMENT IGLESIAS WORKING ELEMENT FBO GYRUS ACMI, INC EIWE BP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other