BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK CUTTING FORCEPS, 5MM, 33CM

    MDR report key: 12580368 · Received October 5, 2021

    Report

    Report Number
    3011050570-2021-00109
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Report Date
    October 29, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925035867
    PMA / PMN Number
    K142759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS INSPECTED, BASED ON THE RESULTS OF THE INSPECTION AND LEGAL MANUFACTURER'S INVESTIGATION, NO ENERGY POWER OUTPUT WAS DIRECTED TO THE JAW DUE TO A LOOSE WIRE LEADING TO AN INTERMITTENT CONNECTION INSIDE THE HANDLE. THE OBSERVED FAILURE IS A KNOWN PHENOMENON RESULTING FROM THE JAWS COMING IN CONTACT WITH EACH OTHER INSTEAD OF TISSUE WHEN USING TO GRASP. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): ON PAGE 3 OF THE DEVICE IFU (P9100528-001_AD), IT STATES: "IF FORCEPS JAWS COME IN CONTACT WITH EACH OTHER WHEN THE POWER IS ACTIVATED, INSTRUMENT WILL SHORT OUT AND THE GENERATOR DISPLAY WILL SHOW ¿RE-GRASP¿. RELEASE THE FORCEPS JAWS SO THEY ARE NOT IN CONTACT WITH EACH OTHER AND THE DEVICE WILL BECOME OPERATIONAL." ON PAGE 4, THE DEVICE HANDLING IS MENTIONED: "KEEP THE ACTIVE ELECTRODES IN SIGHT DURING USE. INADVERTENT ACTIVATION OR MOVEMENT OF THE INSTRUMENT OUTSIDE THE FIELD OF VISION MAY RESULT IN PATIENT INJURY." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER RESPONSE AND UPDATES. COMMUNICATION WITH THE CUSTOMER CONVEYED THE FOLLOWING INFORMATION: CUSTOMER STATED THEY CANNOT TELL EXACTLY WHO USED THE DEVICE, BUT THEY KNOW IT IS A CHIEF PHYSICIAN OR WARD PHYSICIAN THAT HAVE USED THE DEVICE. THEY ARE NOT SURE WHAT DATE THE DEVICE WAS USED, THEY CANNOT PROVIDE THE NAME OF THE OPERATOR OF THE DEVICE. NO FURTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER (B)(4) OLYMPUS SITE FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION IS STILL PENDING. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    UPDATES ON EVENT OR PROBLEM REPORTED: THE PROCEDURE WAS LAPAROSCOPIC SALPINGECTOMY.

    Description of Event or Problem · 0

    AS REPORTED, THE DEVICE STOPPED WORKING DURING A PROCEDURE AFTER A SHORT WHILE OF USE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. THE DELAY WAS APPROXIMATELY 5 MINUTES. THE PRODUCT WAS CONNECTED TO AN ESG-400 GENERATOR. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473995 PK CUTTING FORCEPS, 5MM, 33CM PK CUTTING FORCEPS GEI GYRUS ACMI, INC PK-CF0533 FR115693 00821925035867

    Patients

    Seq Age Sex Outcome Treatment
    1 ESG 400 GENERATOR.