BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLIFT®

    MDR report key: 16245649 · Received January 26, 2023

    Report

    Report Number
    16245649
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 11, 2023
    Report Date
    January 11, 2023
    Manufacturer
    PETERS SURGICAL
    Product Code
    NWV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPE TRIAGE PERSONNEL RECEIVED A CALL FROM DOCTOR CONCERNING A SURGERY HE PERFORMED WHILE USING A FAULTY PIECE OF EQUIPMENT. HE STATES THAT HE WAS USING A T'LIFT SINGE-USE LAPAROSCOPIC RETRACTION SYSTEM WHICH IS USED TO GO THROUGH THE ABDOMINAL WALL TO HOLD THE OVARY OUT OF THE WAY FOR SURGERY. DOCTOR SAYS IT DEPLOYS LIKE AN IUD AND WHEN HE USED IT, A PIECE OF THE EQUIPMENT WAS BROKEN OFF AND DISCHARGED INTO THE ABDOMEN. IT WAS ABOUT THE SIZE OF 3MM-1MM, AND IT WAS RECOGNIZED RIGHT AWAY. THEY SEARCHED FOR THE PIECE BUT WAS UNABLE TO LOCATE IT. SINCE THE DEVICE IS NOT RADIOPAQUE, THE SURGEON WAS UNABLE TO LOCATE THIS PIECE AND WAS FORCED TO CLOSE WITH IT INSIDE. DOCTOR DISCLOSED THIS TO THE PATIENT'S RELATIVE RIGHT AFTER SURGERY BUT THE PATIENT WAS ASLEEP, AND PATIENT HAS NOT HAD A CONVERSATION WITH THEIR SIGNIFICANT OTHER. DOCTOR DID ANSWER ALL THE QUESTIONS AND CONCERNS THAT THE PATIENT'S SIGNIFICANT OTHER HAD AT THE TIME. THE OR MANAGER IS AWARE ACCORDING TO HIS STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855960 TLIFT® LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC NWV PETERS SURGICAL AW16280 B21140D

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA Female