BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 21482532 · Received February 27, 2025

    Report

    Report Number
    3005099803-2025-00615
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 28, 2025
    Report Date
    April 17, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020715
    PMA / PMN Number
    K210266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150301 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ANCHOR EXCHANGE FAILURE TO RELEASE. BLOCK H11: THE RETURNED OVERSTITCH ESS SX WAS ANALYZED. A VISUAL INSPECTION WAS PERFORMED, AND NO DAMAGES WERE FOUND. IT WAS UNABLE TO CONFIRM THE REPORTED EVENT SINCE THE ANCHOR EXCHANGE WAS NOT RETURNED. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS CAUSE NOT ESTABLISHED, SINCE THE ANALYSIS OF THE AVAILABLE INFORMATION AND PRODUCT ANALYSIS OF THE RETURNED DEVICE DID NOT IDENTIFY ANY EVIDENCE OF EITHER THE ALLEGED ISSUE(S) OR ANY DEFECT ON THE DEVICE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150301 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ANCHOR EXCHANGE FAILURE TO RELEASE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS ATTEMPTED TO BE USED DURING A TRANSORAL OUTLET REDUCTION PROCEDURE PERFORMED ON (B)(6) 2025. BEFORE THE PROCEDURE A PART OF THE ANCHOR GOT STUCK ON THE ANCHOR EXCHANGE. THE PROCEDURE OUTCOME IS STILL UNKNOWN. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS ATTEMPTED TO BE USED DURING A TRANSORAL OUTLET REDUCTION PROCEDURE PERFORMED ON (B)(6) 2025. BEFORE THE PROCEDURE A PART OF THE ANCHOR GOT STUCK ON THE ANCHOR EXCHANGE. THE PROCEDURE OUTCOME IS STILL UNKNOWN. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810670 OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-SX1 2023120876 20811955020715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown