BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS,5MM/33CM

    MDR report key: 15919464 · Received December 5, 2022

    Report

    Report Number
    3005975494-2022-00068
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 7, 2022
    Report Date
    December 5, 2022
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925011533
    PMA / PMN Number
    K100896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE EVALUATION , THE FOLLOWING WERE NOTED : A VISUAL INSPECTION ON THE AS IS RECEIVED CONDITION OF THE DEVICE; THE DEVICE WAS RETURNED IN NON-ORIGINAL PACKAGING WITH NO SIGNS OF PHYSICAL DAMAGE ON THE HANDLE OR CABLE. THE DEVICE WAS RECEIVED WITH THE JAWS OPENED, LOCK ON. A VISUAL INSPECTION INDICATES THAT THERE IS MINOR DRIED RESIDUE ON JAWS WHICH IS CONSISTENT WITH USE. THE JAW SYMMETRY IS BALANCED, NO VISUAL DAMAGE NOTED. THE FIRST POINT OF CONTACT FOR THE JAWS IS AT THE FIRST TEETH OF THE JAW; THIS IS CONSISTENT WITH STANDARD. THE JAW APERTURE MEASUREMENT WAS TAKEN INSIDE THE FIRST TEETH OF THE JAW, MEASURED AT 300", (STANDARD IS .300¿ +/- .100¿). THE JAW MESH IS ABNORMAL AND APPEARS NO GOOD. THE INSULATION OF THE JAW LEGS WAS INSPECTED AND FOUND SOME SLITS AND TEARS ON MULTIPLE JAW LEGS WHICH ARE EXPOSING METAL. THE FLARE IS INTACT, WAS UNABLE TO SEE ANY CRACKS. TESTING PERFORMED, GRASPED A PIECE OF DENTAL DAM WITH THE JAW AND EXTENDED THE BLADE, THE BLADE WAS ABLE TO CUT HOWEVER, STICKY RESIDUE IDENTIFIED ON THE BLADE RESTRICTED THE BLADE FROM RETRACTING SMOOTHLY. THE LOCK FUNCTION IS WORKING PROPERLY AS INTENDED AND THE SHAFT HAS NO SIGNS OF DENTS OR DEFORMITIES. THE DEVICE PLUGGED INTO THE TEST G400 GENERATOR; THE GENERATOR DISPLAYED HALO 5MM CUT FORCEP, POWER SETTING VP3 35; THIS IS THE STANDARD DEFAULT SETTING. PERFORMED TESTING BY GRASPING A WET COTTON PAD SOAKED IN SALINE AND PRESSED THE BLUE ACTIVATION SWITCH. INSPECTION OBSERVED VAPORS OF MOISTURE INDICATING OUTPUT POWER WAS BEING PROVIDED THROUGH THE DISTAL END. CONNECTED A FOOTSWITCH AND PRESSED THE BLUE COAG FOOT PEDAL OBSERVING VAPORS OF MOISTURE AGAIN. TESTING ACTIVATED THE HANDPIECE SEVERAL TIMES AND WAS UNABLE TO REPLICATE THE CUSTOMER'S ISSUE AS THE HANDPIECE WAS WORKING WITH NO ERRORS GENERATED ON THE TEST G400 GENERATOR. AS THE EVALUATION RESULTED IN NOT BEING ABLE TO REPLICATE THE COMPLAINT AND THE DEVICE FUNCTIONED AS INTENDED, THE INITIAL COMPLAINT CANNOT BE CONFIRMED. THE PHENOMENON COULD HAVE LIKELY BEEN A RESULT OF INSUFFICIENT GENERATOR OUTPUT TIMING NOT GIVING THE DEVICE ENOUGH/CONSISTENT ENERGY. ON PAGE 4 OF THE DEVICE IFU (P9100504-001_AH), IT STATES: "WARNING: INSUFFICIENT GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY NOT PROVIDE THE OPERATOR WITH THE DESIRED LEVEL OF COAGULATION." THE DEVICE HISTORY RECORDS (DHR¿S) 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. DHR REVIEW FOR THIS LOT FOUND NO ASSOCIATED NCRS (NONCONFORMANCE'S), REPORTED SCRAP OR RECORDED PROCESS DEVIATIONS RELATING TO THE REPORTED FAILURE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED BY THE HOSPITAL STAFF "THIS FORCEPS WAS MIS-FIRED DURING A PROCEDURE ON (B)(6)2022 WITH NO PATIENT INJURY REPORTED. IN A CALL COMMUNICATION WITH TECHNICAL ASSISTANCE CENTER (TAC) , THE REPORTER PROVIDED THE DEVICE MODEL , LOT NUMBER AND STATED "THERE IS NO REPORTED PATIENT INJURY DUE TO THE DEVICE WOULD NOT CLAMP DOWN". NO HARM, REPORTED, NO PATIENT , NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507830 HALO PKS CUTTING FORCEPS,5MM/33CM ELECTROSURGICAL HANDPIECE SINGLE-USE GEI GYRUS ACMI, INC HACF0533 FR212483 00821925011533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown