BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 19171777 · Received April 24, 2024

    Report

    Report Number
    3005099803-2024-01819
    Event Type
    Death
    Date Received
    April 24, 2024
    Date of Event
    January 1, 2022
    Report Date
    June 10, 2024
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020661
    PMA / PMN Number
    K181141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT IS ESTIMATED AS ACTUAL DATE AND YEAR ARE UNKNOWN. BLOCK G2: REPORT SOURCE OTHER. REPORT SOURCE (OTHER) ATTORNEY. BLOCK H6: IMDRF CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT IS ESTIMATED AS ACTUAL YEAR IS UNKNOWN. BLOCK G2: REPORT SOURCE (OTHER) ATTORNEY. BLOCK H6: IMDRF CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN EVENT DATE. IT WAS REPORTED THE PATIENT DIED. NO OTHER INFORMATION HAS BEEN PROVIDED TO DATE 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 UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN EVENT DATE. IT WAS REPORTED THE PATIENT DIED. NO OTHER INFORMATION HAS BEEN PROVIDED TO DATE DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943415 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death