BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 20804035 · Received November 28, 2024

    Report

    Report Number
    3003994796-2024-00005
    Event Type
    Injury
    Date Received
    November 28, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 27, 2024
    Manufacturer
    MEDICEM TECHNOLOGY S.R.O.
    Product Code
    PKN
    PMA / PMN Number
    K143447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A PATIENT WITH CERVICAL CANCER, DILAPAN-S USED TO DILATE CERVICAL CANAL PRIOR TO TANDEM INSERTION OF RADIOTHERAPY INSIDE THE UTERUS (ON (B)(6) 2024). WHEN DILAPAN-S WAS REMOVED, IT BECAME STUCK AND IT WAS TORN ABOUT 1 TO 2 CM FROM THE HANDLE. IT WAS NOT POSSIBLE TO PULL OUT THE FRAGMENT AND IT WAS PUSHED INTO THE UTERINE CAVITY. THE HCP TRIED TO REMOVE THE FRAGMENT WITH FORCEPS, BUT COULD NOT GRASP IT WELL, AND INSERTED A HYSTEROSCOPE AND TRIED TO REMOVE IT WITH GRASPING FORCEPS BUT COULD NOT GRASP IT WELL AGAIN. A FRAGMENT (1 CM) REMAINED IN THE UTERUS. AT THAT TIME POINT THE RADIOTHERAPY TANDEM WAS NOT INSERTED. THE FRAGMENT WAS SUCCESSFULLY REMOVED USING LONG KOCHER FORCEPS ON (B)(6) 2024. NO OTHER COMPLICATIONS REPORTED, NO SIGNS OF INFECTION REPORTED. DEVICE ENTRAPMENT, FRAGMENTATION AND "DUMBELING" ARE KNOWN COMPLICATIONS THAT MAY OCCUR DURING A DILATION PROCEDURE. THEIR LIST IS EMPHASIZED IN THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE, TOGETHER WITH THE RECOMMENDED STEPS HOW TO PROCEED IN CASE OF THEIR OCCURRENCE AND WARNING THAT THE DEVICE (OR ITS FRAGMENTS) SHOULD NOT BE LEFT IN PLACE FOR MORE THAN 24 HOURS. THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS (CERVICAL CANCER) MIGHT HAVE CONTRIBUTED TO THE FRAGMENTATION OF THE DILATOR DURING REMOVAL ATTEMPTS, CAUSING THE FRAGMENTATION. THE FRAGMENT WAS SUCCESSFULLY REMOVED USING LONG KOCHER FORCEPS (TRANSVAGINALLY). THE REASON FOR REPORTING IS A POTENTIAL RISK OF INFECTION, BECAUSE THE FRAGMENT REMAINED IN THE BODY SIGNIFICANTLY LONGER THAN 24 HOURS (11 DAYS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618438 DILAPAN-S Dilator, cervical, synthetic, osmotic PKN MEDICEM TECHNOLOGY S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other