BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELPOINT V-PATH

    MDR report key: 25036543 · Received April 29, 2026

    Report

    Report Number
    2027111-2026-00531
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 29, 2026
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HEW
    UDI-DI
    00607915138493
    PMA / PMN Number
    K191294
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: BILATERAL SALPINGECTOMY EVENT DESCRIPTION: AFTER THE PROCEDURE, THE DOCTOR PUT AN IRRIGATION VACUUM THROUGH THE 10MM SLEEVE. AS THE DOCTOR PERFORMED THE SUCTION IRRIGATION, THE PLASTIC SLEEVE DETACHED INTO THE PATIENT. THE PATIENT NOTICED THE SLEEVE DETACHED INTO THEIR BODY. THE DOCTOR WAS ABLE TO REMOVE THE PLASTIC SLEEVE FROM THE PATIENT AND THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY [COMPANY REPRESENTATIVE] VIA EMAIL ON 23APR2026: THE PATIENT DID NOT NOTICE THE SLEEVE, AS THEY WERE UNDER ANESTHESIA AT THE TIME OF THE PROCEDURE. THE OBSERVATION WAS MADE BY THE SURGEON AND MYSELF WHILE VIEWING THE MONITOR DURING THE END OF THE CASE. TYPE OF INTERVENTION: REMOVED PLASTIC PIECE FROM PATIENT STATUS: NO CLINICAL IMPACT. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429359 GELPOINT V-PATH CULDOSCOPE (AND ACCESSORIES) HEW APPLIED MEDICAL RESOURCES C2A15 1564838 00607915138493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown