BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T'LIFT

    MDR report key: 16415838 · Received February 22, 2023

    Report

    Report Number
    3005459904-2023-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 21, 2023
    Manufacturer
    PETERS SURGICAL
    Product Code
    NWV
    UDI-DI
    03700393301360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE BATCH RECORDS FOR THE T'LIFT RETRACTION SYSTEM BATCH N°B21140D HAS BEEN PERFORMED. ALL RESULTS OF CONTROLS PERFORMED ARE FOUND COMPLIANT TO THEIR SPECIFICATIONS, INCLUDING RESULTS ON THE INJECTION OF THE COMPONENT BROKEN. NO NON-CONFORMITY HAS BEEN DETECTED DURING THE MANUFACTURING OF THE BATCH. TO DATE, NO OTHER INCIDENT HAS BEEN REPORTED WITH THE BATCH N° B21140D OF T'LIFT. ADDITIONAL TESTS HAVE BEEN CONDUCTED ON 3 RETAINED SAMPLES OF THE INCRIMINATED BATCH OF T'LIFT. THE RESISTANCE OF THE T'LIFT TO A LOAD HAVE BEEN FOUND COMPLIANT TO THE SPECIFICATION. TO DATE, THE INCRIMINATED DEVICE HAS NOT BEEN RETURNED BY THE HEALTHCARE FACILITY TO COMPLETE THE INVESTIGATION THEREFORE THE ROOT-CAUSE CANNOT BE ESTABLISHED.

    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. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LAPAROSCOPIC HYSTERECTOMY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612253 T'LIFT SINGLE-USE RETRACTION SYSTEM NWV PETERS SURGICAL AW16280 B21140D 03700393301360

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female