BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUTECH PISTOL PUSHER

    MDR report key: 23061912 · Received September 16, 2025

    Report

    Report Number
    3012290852-2025-00002
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 8, 2025
    Report Date
    January 16, 2026
    Manufacturer
    OCCLUTECH TIBBI URUNLER SAN.VE TIC. LTD. STI
    Product Code
    OZG
    UDI-DI
    8683463400529
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. A2 AND A4 ARE UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW, INSPECTION PROTOCOLS AND THE PACKAGING OF THE COMPLAINED DEVICE 55PP185 OPP24101_08 REVEALED NO DEVIATIONS. THE FINAL INSPECTION OF THE COMPLAINED OPP REVEALED NO DEVIATIONS AND THE ENVIRONMENTAL CONDITIONS DURING THE STORING WERE WITHIN LIMITS. DURING THE INVESTIGATION, IT WAS POSSIBLE TO GRAB AND RELEASE THE OCCLUDER WITHOUT ANY ISSUE. THE BALL-JAW CONNECTION WITHSTAND A TUG TEST.WITH THE DEVICES BEING COMPATIBLE WITH EACH OTHER AND WITHSTANDING A TUG TEST, A DEVICE-RELATED FAILURE CAN BE EXCLUDED. IT IS POSSIBLE THE COMPLAINED EVENT OCCURRED DUE TO THE APPLICATION OF EXCESSIVE FORCES ONTO THE PUSHER. ANOTHER POSSIBILITY IS, THAT THE PUSHER CABLE WAS NOT SET TO A STRAIGHT LINE, WHICH CAN CAUSE NOT-REPRODUCIBLE ISSUES WITH THE CLOSING MECHANISM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PUSHER AUTO RELEASED DEVICE BEFORE INSERTION, DESPITE THE PUSHER BEING LOCKED. THE PUSHER WORKED AFTER PUSHING THE TRIGGER SEVERAL TIME. PROCEDURE CONTINUED BUT THE DEVICE WAS UNDERSIZED, THE DEVICE WAS RETRACTED. THE PUSHER WAS JAMMED WHEN TRYING TO RELEASE THE DEVICE OUTSIDE THE INTRODUCER. THE TRIGGER WAS PUSHED SEVERAL TIME TO RELEASE THE DEVICE. AFTER THAT THE PUSHER JAMMED AGAIN DESPITE PUSHING THE TRIGGER SEVERAL TIMES. NO PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PUSHER AUTO RELEASED DEVICE BEFORE INSERTION, DESPITE THE PUSHER BEING LOCKED. THE PUSHER WORKED AFTER PUSHING THE TRIGGER SEVERAL TIME. PROCEDURE CONTINUED BUT THE DEVICE WAS UNDERSIZED, THE DEVICE WAS RETRACTED. THE PUSHER WAS JAMMED WHEN TRYING TO RELEASE THE DEVICE OUTSIDE THE INTRODUCER. THE TRIGGER WAS PUSHED SEVERAL TIME TO RELEASE THE DEVICE. AFTER THAT THE PUSHER JAMMED AGAIN DESPITE PUSHING THE TRIGGER SEVERAL TIMES. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271410 OCCLUTECH PISTOL PUSHER PISTOL PUSHER OZG OCCLUTECH TIBBI URUNLER SAN.VE TIC. LTD. STI 55PP185 OPP24101 8683463400529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female