BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 23254945 · Received October 9, 2025

    Report

    Report Number
    3005099803-2025-05163
    Event Type
    Death
    Date Received
    October 9, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 9, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B2 AND B3: THE DEATH AND EVENT DATES ARE APPROXIMATE. THE EXACT DATES WERE NOT PROVIDED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION RECEIVED INFORMATION VIA A SOCIAL MEDIA POST THAT THE INITIAL REPORTER KNEW A WOMAN THAT HAD AN ESG PROCEDURE AND THE WOMAN DIED LAST WEEK. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512835 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY UNK-P-OVERSTITCH_ESS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Death