BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 19741051 · Received July 15, 2024

    Report

    Report Number
    3005099803-2024-03303
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 29, 2024
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    PMA / PMN Number
    K181141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 : DEVICE CODE A150208 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE STUCK. INVESTIGATION SUMMARY: THE SYSTEM WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. A FUNCTIONAL TEST WAS PERFORMED ON THE HANDLE BY OPEN AND CLOSING THE NEEDLE BODY AND IT WAS FOUND THAT THE NEEDLE SHAFT WAS WORKING AS EXPECTED AND NOT STICKING. THE HANDLE WAS ALSO TESTED WITH SUTURING SEQUENCE AND WAS FOUND TO PERFORM AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED AS INTENDED, NO ISSUE WAS FOUND WITH THE DEVICE. THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE CONCLUSION CODE OF NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 0

    BLOCK H6 DEVICE CODE A150208 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE STUCK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED ON (B)(6) 2024. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE AND THE CATHETER WERE TRAPPED INSIDE THE TISSUE. THE PHYSICIAN HAD TO HAD TO PERFORM AN ANGULATION WITH THE GASTROSCOPE TO REMOVE FROM THE TISSUE. THE PHYSICIAN ALSO STATED THAT THE ANCHOR EXCHANGE CATHETER KEPT DROPPING OFF THE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED ON (B)(6) 2024. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE AND THE CATHETER WERE TRAPPED INSIDE THE TISSUE. THE PHYSICIAN HAD TO HAD TO PERFORM AN ANGULATION WITH THE GASTROSCOPE TO REMOVE FROM THE TISSUE. THE PHYSICIAN ALSO STATED THAT THE ANCHOR EXCHANGE CATHETER KEPT DROPPING OFF THE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268848 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 2023100796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown