BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 23278126 · Received October 15, 2025

    Report

    Report Number
    3005099803-2025-05149
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    January 28, 2026
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6. DEVICE CODE A040609 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE SHAFT BENT. DEVICE CODE A1702 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ANCHOR EXCHANGE FAILURE TO RETRIEVE ANCHOR. ADDITIONAL INFORMATION, B5: INFORMATION RECEIVED ON OCTOBER 16, 2025, REPORTED THE SPECIFIC LOCATION OF THE PROCEDURE. INFORMATION RECEIVED ON OCTOBER 24, 2025, REPORTED THE SIZE OF THE PERFORATION, FIRST DAY OF HOSPITALIZATION, AND OUTCOME OF THE STENT FIXATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A STENT FIXATION PROCEDURE ON (B)(6)2025. DURING THE PROCEDURE, WHILE TRYING TO PLACE THE SECOND SUTURE, THE PHYSICIAN HAD DIFFICULTY UNLOADING THE ANCHOR FROM THE NEEDLE BODY BECAUSE IT WAS BENT. THE PHYSICIAN REMOVED THE DEVICE, AND A PERFORATION WAS OBSERVED. CLIPS WERE PLACED TO CLOSE THE PERFORATION. THE PATIENT IS REPORTED TO BE STABLE, HOWEVER IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED OR THEIR HOSPITALIZATION WAS PROLONGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE HOSPITALIZATION, DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ESOPHAGEAL STENT FIXATION PROCEDURE ON (B)(6) 2025. WHILE PLACING THE SECOND SUTURE, THE PHYSICIAN HAD DIFFICULTY UNLOADING THE SUTURE FROM THE NEEDLE BODY. UPON INSPECTION, BOTH THE NEEDLE BODY AND THE ANCHOR WERE FOUND TO BE BENT. THE DEVICE WAS REMOVED, AND A 1-2CM PERFORATION WAS OBSERVED AT THE UPPER ESOPHAGEAL SPHINCTER. CLIPS WERE PLACED TO CLOSE THE PERFORATION. THE STENT FIXATION WAS COMPLETED. THE PATIENT IS REPORTED TO BE STABLE; HOWEVER, IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN AMOUNT OF TIME ON (B)(6) 2025 AS A RESULT OF THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179331 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 2024060258 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R