BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS,5MM/33CM

    MDR report key: 16465550 · Received March 2, 2023

    Report

    Report Number
    3005975494-2023-00038
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 10, 2023
    Report Date
    May 19, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    UDI-DI
    00821925011533
    PMA / PMN Number
    K100896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INITIAL MEDWATCH INCORRECTLY REPORTED THE SITE REGISTRATION NUMBER. THE SITE REGISTRATION NUMBER IS 3011050570. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S EVALUATION AND FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE RESULTS OF EVALUATION PROVIDED THE FOLLOWING: THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING HOWEVER OPENED AND USED. THE TEETH OF THE JAWS SHOWED SIGNS OF DRIED FOREIGN MATERIAL UNDER A MICROSCOPE, INDICATING USE. THE INSULATION OF THE LEGS HAD CUTS AND TEARS, EXPOSING THE METAL LEGS, AND A CRACK WAS OBSERVED ON THE FLARE OF THE DEVICE. THE SHAFT SHOWED NO SIGNS OF DENTS OR BENDS, AND THE JAW SYMMETRY AND MESH APPEARED GOOD. THE JAW APERTURE MEASUREMENT WAS TAKEN INSIDE THE FIRST TEETH OF THE JAW AND WAS MEASURED AT .375". TO CHECK THE DEVICE'S FUNCTIONALITY, A PIECE OF DENTAL DAM WAS GRASPED, AND THE BLADE WAS EXTENDED, WHICH CONFIRMED THAT IT COULD CUT THE DENTAL DAM SMOOTHLY. THE DEVICE WAS THEN PLUGGED INTO THE TEST GYRUS G400 GENERATOR; THE GENERATOR DISPLAYED "HALO 5MM CUT FORCEP VP3 35"; THIS IS THE DEFAULT SETTING. THE DEVICE WAS THEN TESTED WITH A WET COTTON PAD SOAKED IN SALINE, AND THE BLUE ACTIVATION SWITCH WAS PRESSED SEVERAL TIMES WITH DIFFERENT POWER SETTINGS. EACH TIME, VAPORS OF MOISTURE WERE PRESENT, INDICATING THAT ENERGY WAS BEING DISTRIBUTED THROUGH THE DISTAL END. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE REPORTED ISSUE OF TISSUE NOT SEALING COULD NOT BE CONFIRMED AS THE DEVICE WORKED AS INTENDED DURING THE INSPECTION. THE OBSERVED CUTS ON THE INSULATION EXPOSING METAL AND THE CRACK ON THE FLARE MAY SUGGEST A POTENTIAL CONTRIBUTION TO INTERMITTENT COAGULATION, WHICH COULD POTENTIALLY BE ATTRIBUTED TO THE REPORTED ISSUE. HOWEVER, THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE CONCLUSIVELY SPECIFIED. THE DEVICE IFU (INSTRUCTION FOR USE_ P9100504-001_AH) ADDRESSES THIS: " FOR OPTIMUM PERFORMANCE, KEEP JAW SURFACES FREE OF DEBRIS; BOTH COAGULATING SURFACES SHOULD BE IN EQUAL CONTACT WITH TISSUE FOR OPTIMUM COAGULATION." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    OLYMPUS REPRESENTATIVE IN BEHALF OF THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SEAL TISSUE ALL THE WAY WHEN USED. THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC SALPINGECTOMY PROCEDURE. THE SUBJECT DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. IN A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS STATED THAT THE TOTAL LENGTH OF THE PROCEDURE WAS 31 MINUTES WITH NO HARM REPORTED OTHER THAN LONGER ANESTHESIA TO THE PATIENT AS THE USER NEED TO TROUBLESHOOT THE DEVICE AND HAD TO WAIT TO OPEN THE SECOND DEVICE. THE REPORTED PROBLEM ACCORDING TO THE CUSTOMER DID NOT AFFECT THE THERAPEUTIC OUTCOME OF THE PROCEDURE. NO HARM WAS REPORTED, NO PATIENT HARM , NO USER INJURY REPORTED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504125 HALO PKS CUTTING FORCEPS,5MM/33CM ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE GEI GYRUS ACMI, INC. HACF0533 FR263178 00821925011533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown