BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEEL LAPAROSCOPIC RETRACTOR, RT

    MDR report key: 23015738 · Received September 10, 2025

    Report

    Report Number
    1223422-2025-00028
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 10, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K133345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THIS REVEEL RETRACTOR WAS VISUALLY INSPECTED, AND THE CONDITION OF THE BENT I-BEAM AND DISPLACEMENT OF THE OVERMOLDED COMPONENT WAS CONFIRMED. THE REVEEL DEVICE IS DESIGNED TO RETRACT TISSUE BY LOADING THE TARGET'S WEIGHT PERPENDICULAR TO THE PLANE OF THE ARMS WHEN ACTUATED. THE ATRAUMATIC TIP IS NOT INTENDED TO SUPPORT LOAD OR HOLD WEIGHT IN ANY OTHER ORIENTATION. MISUSE IN THIS MANNER CAN RESULT IN STRUCTURAL DEFORMATION OR DAMAGE TO THE DEVICE, AS OBSERVED IN THIS CASE. TO HELP PREVENT RECURRENCE, THIS CLARIFICATION HAS BEEN ADDED TO THE INSTRUCTIONS FOR USE (RT083001, IFU 09-39-00555-00) THROUGH ECN-09924, SPECIFYING THE CORRECT ORIENTATION AND INTENDED USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    AT THIS TIME, MSI IS AWAITING THE RETURN OF THE DEVICE IN ORDER TO CONDUCT A FULL INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED AND ADDITIONAL DETAILS ARE AVAILABLE, A FINAL ADVERSE EVENT REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS UNABLE TO WITHSTAND THE WEIGHT OF THE LIVER. TWO DEVICES DISINTEGRATED INTRAOPERATIVELY WHILE IN USE INSIDE THE PATIENT. AT THE TIME OF FAILURE, THE REVEEL WAS NOTED TO HAVE BEEN COMPLETELY OPEN. AT THIS TIME, NO ADDITIONAL PATIENT INJURY BEYOND THE DEVICE MALFUNCTION HAS BEEN REPORTED.

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS UNABLE TO WITHSTAND THE WEIGHT OF THE LIVER. TWO DEVICES DISINTEGRATED INTRAOPERATIVELY WHILE IN USE INSIDE THE PATIENT. AT THE TIME OF FAILURE, THE REVEEL WAS NOTED TO HAVE BEEN COMPLETELY OPEN. AT THIS TIME, NO ADDITIONAL PATIENT INJURY BEYOND THE DEVICE MALFUNCTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488988 REVEEL LAPAROSCOPIC RETRACTOR, RT RETRACTOR, DISPOSABLE GEI MICROLINE SURGICAL RT083001 2405222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown