BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESCULAP PRESTIGE GRASPER

    MDR report key: 17624240 · Received August 24, 2023

    Report

    Report Number
    MW5144954
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 21, 2023
    Manufacturer
    AESCULAP, INC.
    Product Code
    NWV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING LAPAROSCOPIC OVARIAN CYSTECTOMY, DR. (B)(6) INSERTED AN ASCULAP PRESTIGE GRASPER(PART # 8360-00) INTO A TROCAR. ONCE SHE OPENED THE GRASPER, IT REMAINED IN AN OPEN POSITION, SHE HAD DIFFICULTY CLOSING AND REMOVING THE GRASPER FROM THE PATIENT. UPON REMOVAL SCRUB TECHNICIAN NOTED THE JAW OF THE GRASPER SEPARATED FROM THE MAIN BODY, AND SUSPECTED A PIN WAS MISSING. DRS. (B)(6) INSPECTED THE STERILE FIELD WHILE SCRUB TECHNICIAN SEARCHED FOR SUSPECTED ITEM ON BACK TABLE. I SEARCHED THE FLOOR AND SURROUNDING AREA. NO SUSPECTED PIN NOTED. RADIOLOGY WAS CALLED WHILE SURGERY CONTINUED. ADDITIONAL SCRUB TECHNICIAN ENTERED THE ROOM, THEIR SEARCH REVEALED A METAL FRAGMENT ON THE FLOOR. RADIOLOGY PERFORMED AN XRAY, NO FOREIGN BODY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726673 AESCULAP PRESTIGE GRASPER LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC NWV AESCULAP, INC. 8360-00

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention