BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO SMARTCAP

    MDR report key: 20434761 · Received October 11, 2024

    Report

    Report Number
    1651395-2024-00021
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FAJ
    UDI-DI
    00677964059087
    PMA / PMN Number
    K093665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDO SMARTCAP TUBING SET WAS RETURNED TO STERIS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE BODY CAP COMPONENT HAD DETACHED FROM THE BODY, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, A DEFINITIVE ROOT CAUSE OF THE SEPARATION COULD NOT BE DETERMINED. A COMPLAINT REVIEW WAS CONDUCTED AND CONFIRMED THIS TO BE AN ISOLATED EVENT FOR THE SUBJECT LOT. STERIS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR ENDO SMARTCAP TUBING. THE TUBING WAS QUICKLY REPLACED, AND THE SCOPE FUNCTIONED CORRECTLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334667 ENDO SMARTCAP TUBING FAJ MEDIVATORS INC. 100145CO2EXT (10)633334 00677964059087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown