BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12025328 · Received June 18, 2021

    Report

    Report Number
    3011050570-2021-00078
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 26, 2021
    Report Date
    October 27, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925036178
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, G6, H2, H6 AND H10. THE CUSTOMER WAS CONTACTED AND HAS NOT PROVIDED THE LOT NUMBER FOR THIS DEVICE. DHR (DEVICE HISTORY RECORDS) REVIEW COULD NOT BE PERFORMED FOR THE LOT ASSOCIATED WITH THIS DEVICE. SINCE THE DEVICE IS NOT RETURNING TO OLYMPUS, NO DEVICE EVALUATION COULD BE PERFORMED. THE COMPLAINT COULD NOT BE FULLY CONFIRMED DUE TO THE DEVICE NOT RETURNING. HOWEVER, SINCE THE COMPLAINT CANNOT BE FULLY CONFIRMED, THE OBSERVED FAILURE IS A KNOWN PHENOMENON LIKELY RESULTING FROM INCORRECT PLACEMENT OF THE RATCHET SWITCH THAT CONTROLS THE JAW OPEN/CLOSE FEATURE UPON INITIAL INSPECTION OF THE DEVICE. ON PAGE 3 OF THE DEVICE IFU (INSTRUCTION FOR USE) (910111-001_EE), IT STATES: THE DEVICE IS PACKAGED IN THE RATCHET OFF MODE. WHEN IN THE RATCHET MODE, THE JAWS WILL STAY CLOSED IF THE FORCEPS GRIP IS RELEASED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATIONS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION, LEGAL MANUFACTURER'S UPDATED INVESTIGATION AND CORRECTIONS TO THE REPORT. THE SUBJECT DEVICE HAS BEEN RECEIVED AND COMPLETED EVALUATION. A VISUAL INSPECTION INDICATES THAT THERE IS DRIED TISSUE ON JAWS CONSISTENT WITH USE. THE JAW SYMMETRY IS BALANCED. THE FIRST POINT OF CONTACT FOR THE JAWS IS AT THE DISTAL END; THIS IS CONSISTENT WITH STANDARD. THE JAW APERTURE MEASUREMENT COULD NOT BE MEASURED DUE TO THE JAWS BEING STUCK. THE INSULATION OF THE JAW LEGS WAS INSPECTED AND FOUND LARGE CUTS WITH TWO AREAS OF EXPOSED METAL. THE FLARE IS IN INTACT AND HAS NO CRACKS. THE BLADE EXTENDS/RETRACTS, BUT COULD NOT BE TESTED WITH A DENTAL DAM AS THE JAWS WOULD NOT OPEN. THE LOCK FUNCTION ENGAGES/RELEASES AS DESIGNED AND THE SHAFT IS NORMAL. THE DEVICE WAS PLUGGED INTO THE TEST GENERATOR; THE GENERATOR DISPLAYED VP3/35; THIS IS THE CORRECT DEFAULT SETTING. THE BASE OF THE LEGS AT THE DISTAL END ARE BENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE LIKELY CAUSE OF THE JAWS STUCK IN THE CLOSED POSITION IS DUE TO THE BENT LEGS AT THE DISTAL END. THE LIKELY CAUSE OF THE EXPOSED METAL FROM THE DAMAGED LEG INSULATION MAY BE DUE TO MISHANDLING. THE OBSERVED FAILURE IS A KNOWN EVENT RESULTING FROM APPLYING EXCESSIVE STRESS NEAR THE DISTAL END OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) STATES: "IF USING THE TIP AND SHAFT OF THE INSTRUMENT TO LEVERAGE TISSUE, ENSURE THE JAWS ARE CLOSED TO PREVENT DEFORMATION OF THE JAWS." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUTTING FORCEPS WOULD NOT OPEN UPON USING IT FOR THE FIRST TIME. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SECOND LIKE DEVICE. THE LOT/SERIAL NUMBER USED WAS NOT PROVIDED. THERE WAS NO PATIENT IMPACT OR HARM REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919632 PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK) PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK) GEI GYRUS ACMI, INC 920005PK 00821925036178

    Patients

    Seq Age Sex Outcome Treatment
    1