BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA INSTRUMENTS (SYMMETRY SURGICAL INC.)

    MDR report key: 18727304 · Received February 16, 2024

    Report

    Report Number
    3007208013-2024-00005
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 20, 2024
    Report Date
    March 22, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GEI
    UDI-DI
    00887482128510
    PMA / PMN Number
    K040855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING RETURN OF THE DEVICE AND/OR ADDITIONAL DETIALS TO COMPLETE THE EVALUATION.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE DEVICES, A VISUAL INSPECTION WAS PERFORMED WHICH FOUND THAT THE DEVICE SHOWED SIGNS OF MODERATE USE, ALONG WITH NICKS, SCRATCHES, AND DINGS ON THE JAWS FROM USE. THE DEVICE WAS RETURNED WITH A DETACHED PIECE OF THE JAW MECHANISM (SMALL THIN PLATE). THE JAWS OF THE DEVICE WERE FOUND TO BE LOOSE AS THE INNER MECHANISM OF THE JAW WERE NOT HELD IN BY SCREWS AT IT SHOULD BE. ROOT CAUSE: THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE STRESS ON THE JAWS. THERE ARE A FEW POSSIBILITIES THAT COULD CAUSE THIS OUTCOME: THE DEVICE WAS USED TO GRAB AN ITEM THAT WAS TOO LARGE WHICH CAUSED THE JAWS TO LOCK IN THE OPEN POSITION. WHEN THEY WERE FORCED CLOSED AS DESCRIBED IN THE COMPLAINT, THE JAW MECHANISM SNAPPED, OR, THE DEVICE COULD HAVE BEEN DAMAGED FROM A PREVIOUS SURGERY OR FROM REPROCESSING; WHEN THEY WERE ACTUATED AND GRASPED TO SOMETHING THE LOCKING MECHANISM BROKE. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.

    Description of Event or Problem · 0

    PER THE COMPLAINANT, "I WAS THE OBGYN FACULTY ON THIS CASE. IT WAS A ROBOTIC ASSISTED HYSTERECTOMY FOR FIBROIDS AND THIS 5MM LAPAROSCOPIC TENACULUM WAS PLACED THRU AN 8MM PORT WITH THE TEETH CLOSED TO RETRACT DOWN BY THE CERVIX. WHILE IT INITIALLY OPENED TO GRASP THE CERVICAL TISSUE, IT DIDN'T SEEM TO BE ABLE TO STAY CLOSED ENOUGH TO APPLY ANY TRACTION TO THE TISSUE. AS SUCH, WE RELEASED THE CERVICAL TISSUE TO REMOVE THE DEVICE . THEN THE TENACULUM WOULD NOT CLOSE AS IF SOMETHING WAS JAMMED, KEEPING US FROM BEING ABLE TO CLOSE IT FROM THE EXTERNAL HANDLE. I WAS NOT ABLE TO MANUALLY CLOSE THE TENACULUM TEETH WITH A LAPAROSCOPIC GRASPER. UNDER ROBOTIC VISUALIZATION AS THE ROBOTIC CAMERA WAS STILL DOCKED, THE JAMMED OPEN TENACULUM WAS THEN BROUGHT TO THE 8MM PORT, GENTLE TRACTION WAS APPLIED AND THE TEETH CLOSED AND THE TENACULUM WAS REMOVED. WHILE DIRECTLY WATCHING THE PORT DURING THE REMOVAL PROCESS, THIS SMALL THIN PLATE FELL OUT OF THE PORT AND IT WAS IMMEDIATELY RETRIEVED. NO OTHER PIECES WERE SEEN. INSPECTION OF THE INSTRUMENT AND COMPARISON TO AN INTACT 5MM LSC TENACULUM APPEARS TO US THAT ONLY THAT 1 PIECE WAS MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431575 ULTRA INSTRUMENTS (SYMMETRY SURGICAL INC.) TENACULUM GEI SYMMETRY SURGICAL INC. 90-1008 110221 00887482128510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown