BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK CUTTING FORCEPS, 5MM, 33CM

    MDR report key: 12406057 · Received September 1, 2021

    Report

    Report Number
    3011050570-2021-00097
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    July 1, 2021
    Report Date
    October 5, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925035867
    PMA / PMN Number
    K142759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE INVESTIGATION FINDINGS. NEW INFORMATION IS REPORTED IN H6 AND H10. THE DEVICE DID NOT RETURN TO OLYMPUS, SO NO DEVICE EVALUATION COULD BE PERFORMED. ADDITIONALLY, SINCE THE LOT NUMBER WASN'T PROVIDED BY THE CUSTOMER, THE DHR COULD NOT BE FOUND AND REVIEWED. PER THE EVENT DESCRIPTION: "NURSE SAID THE COMPANY MAY BE CONTACTED REGARDING THE CUTTING FORCEPS, ALTHOUGH THERE IS NO EVIDENCE THE DEVICE IS AT FAULT." "NURSE SAYS IT IS CLEARLY REFERENCED ON THE CONSENT FORM THAT ISSUES SUCH AS THE ABOVE MAY HAPPEN AS POST-OP BLEEDS CAN UNFORTUNATELY OCCUR FROM ANY PROCEDURE." AS STATES ABOVE, THE CONSENT FORM THE NURSE MENTIONS STATES POSSIBILITY OF POST-OP BLEEDS. IN ADDITION, THE DEVICE IFU RECOMMENDS TO FULLY READ AND COMPREHEND THE INSTRUCTIONS FOR USE. IN ADDITION, THE NURSE ALSO STATED THERE IS NO EVIDENCE THE DEVICE WAS AT FAULT. ON PAGE 4 OF THE DEVICE IFU (P9100528-001_AD ), IT STATES: "FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS, AND CAUTIONS MAY LEAD TO SERIOUS SURGICAL CONSEQUENCES OR INJURY TO THE PATIENT." THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE CUSTOMER (NURSE) AFTER A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH) USING A PK CUTTING FORCEPS FOR ESG400, THE PATIENT EXPERIENCED REDUCED BLOOD PRESSURE AND WAS TAKEN BACK TO THE OPERATING ROOM, THEN TRANSFERRED TO ANOTHER HOSPITAL FOR A HIGHER LEVEL OF CARE. SEQUENCE OF EVENTS AS FOLLOWS: LAVH PERFORMED. UPON OBSERVATION AT THE END OF THE PROCEDURE EVERYTHING WAS NOTED TO BE DRY AND OK. POST-OPERATIVELY THE PATIENT EXPERIENCED REDUCED BLOOD PRESSURE AND WAS RETURNED TO THE OPERATING ROOM WHERE BLEEDING WAS NOTED FROM THE UTERINE ARTERY. THE PATIENT LOST APPROXIMATELY 2 LITERS OF BLOOD. AN UNSPECIFIED SURGICAL PROCEDURE WAS PERFORMED TO TREAT THE BLEEDING UTERINE ARTERY, THEN THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A HIGHER LEVEL OF CARE. THE PATIENT RECOVERED FINE AND WAS SATISFIED AT THE TIME. THE NURSE FURTHER REPORTED THERE IS NO EVIDENCE THAT THE CUTTING FORCEPS ARE AT FAULT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED, AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305716 PK CUTTING FORCEPS, 5MM, 33CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC PK-CF0533 UNKNOWN 00821925035867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R