BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 23624027 · Received November 21, 2025

    Report

    Report Number
    3005099803-2025-06116
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 21, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020661
    PMA / PMN Number
    K181141
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 DEVICE CODE A040609 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE SHAFT BENT. IMDRF CODE F2301 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF CODE F1901 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL SURGERY. IMDRF CODE E0506 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HEMORRHAGE, MAJOR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A FISTULA REPAIR ON OCTOBER 17, 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT. UPON REMOVAL OF THE FIRST OVERSTITCH DEVICE, IT WAS OBSERVED THERE WAS TISSUE DAMAGE TO THE ESOPHAGUS, WHICH CAUSED MAJOR BLEEDING. THE BLEEDING WAS TREATED WITH PURASTAT. AN ATTEMPT WAS MADE TO COMPLETE THE PROCEDURE WITH A SECOND OVERSTITCH DEVICE, WHICH WAS ALSO BENT. THE SECOND OVERSTITCH DEVICE DID NOT CAUSE ANY COMPLICATIONS. THE PHYSICIAN ATTEMPTED TO CLOSE THE FISTULA USING CLIPS. HOWEVER, THE CLIPS WERE NOT SUCCESSFUL. THE PATIENT HAD AN ADDITIONAL SURGERY TO SUCCESSFULLY CLOSE THE FISTULA. THE PATIENT HAS MADE A FULL RECOVERY. THIS REPORT IS RELATED TO THE FIRST OF TWO OVERSTITCH DEVICES AND TWO OVERSTITCH SUTURES USED IN THE SAME PROCEDURE. PLEASE REFER TO REPORTS 3005099803-2025-06280 FOR THE FIRST OVERSTITCH SUTURE, 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE, AND 3005099803-2025-06281 FOR THE SECOND OVERSTITCH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076761 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 2025030080 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention