BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)

    MDR report key: 11785761 · Received May 6, 2021

    Report

    Report Number
    3011050570-2021-00072
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    May 28, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925036178
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE RETURNED DEVICE WAS EVALUATED. INSPECTION INDICATES THAT THERE IS MINOR DRIED TISSUE ON THE BOTTOM JAW CONSISTENT WITH USE. THE DEVICE JAWS HAD SYMMETRY AND A DISTAL TIP DISTANCE THAT WERE AMONG THE STANDARD. THE JAW MESH WAS NORMAL, AND THE CUTTING FEATURE WAS ABLE TO CUT THE DENTAL DAM AS DESIGNED. WHEN PLUGGED INTO A GENERATOR, THERE WERE NO ERROR CODES. ADDITIONALLY, WHEN PLUGGED INTO THE GENERATOR, THE DISTAL JAWS WERE ABLE TO HEAT UP AND COAGULATE AS DESIGNED. THE FUNCTIONALITY OF THE DEVICE WAS TESTED MULTIPLE TIMES WITH DIFFERENT POWER OUTPUTS AND THE DEVICE HEATED UP AS INTENDED. BASED ON THE DEVICE EVALUATION, IT IS UNABLE TO REPLICATE THE USER COMPLAINT OF DEVICE WOULD NOT FIRE AS THE DEVICE WAS FUNCTIONING PROPERLY AS INTENDED, HOWEVER INSPECTION DID OBSERVE SLITS IN THE INSULATION EXPOSING METAL WHICH COULD POSSIBLY ATTRIBUTE TO THE CUSTOMER'S ISSUE. THE OBSERVED FAILURE IS A KNOWN PHENOMENON AND IS PRODUCED AS A RESULT OF ERROR IN OPERATING THE DEVICE. ON PAGE 2 OF THE DEVICE IFU (910111-001_EE), ERROR IN LACK OF COAGULATION IS ADDRESSED: "WARNING: INSUFFICIENT GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY NOT PROVIDE THE OPERATOR WITH THE DESIRED LEVEL OF COAGULATION." THE DHRS (DEVICE HISTORY RECORDS FOR THIS PRODUCT HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE DEVICE EVALUATION IS PENDING, THEREFORE, THE ROOT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE DETERMINED AT THIS TIME. ADDITIONAL EVENT/PATIENT INFORMATION HAS BEEN REQUESTED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SALPINGO-OOPHORECTOMY PROCEDURE THE HANDPIECE DEVICE WOULD NOT FIRE WHEN INSERTED THROUGH THE PORT TO CAUTERIZE A BLEED. AN UNKNOWN DELAY TO THE PROCEDURE WAS NOTED. THE INTENDED PROCEDURE HOWEVER WAS COMPLETED USING ANOTHER HANDPIECE. THE SERIAL NUMBER USED WAS NOT PROVIDED. THE EVENT ACCORDING TO THE REPORTER SLOWED DOWN THE PROCEDURE. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682820 PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK) PKS CUT/FCP ENERGY DEVICES GEI GYRUS ACMI, INC 920005PK FR103782 00821925036178

    Patients

    Seq Age Sex Outcome Treatment
    1 FOOT PEDAL.