BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERSTITCH 2-0 POLYPROPYLENE SUTURE

    MDR report key: 23623297 · Received November 21, 2025

    Report

    Report Number
    3005099803-2025-06281
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 12, 2026
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020661
    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 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 DEVICE CODE A040609 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ANCHOR BENT. IMDRF CODE F2301 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF CODE F1901 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL SURGERY.

    Additional Manufacturer Narrative · 0

    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 DEVICE CODE A040609 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ANCHOR BENT. IMDRF CODE F2301 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF CODE F1901 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL SURGERY. DEVICE EVALUATION: BLOCK H11 THE DEVICE DID NOT RETURN FOR ANALYSIS; HOWEVER, THE CUSTOMER PROVIDED SOME PICTURES. A MEDIA ANALYSIS WAS PERFORMED, WHERE IT IS POSSIBLE TO IDENTIFY THE ANCHOR OF THE OVERSTITCH SUTURE BENT INTO THE NEEDLE OF THE OVERSTITCH. ADDITIONALLY, A SHORT PIECE OF SUTURE BREAK IS VISIBLE. FOR THIS REASON, THERE IS ENOUGH EVIDENCE TO CONFIRM THE REPORTED EVENT OF ANCHOR BENT. BASED ON THE EVENT DESCRIPTION, MEDIA INSPECTION, AND INFORMATION PROVIDED BY THE CUSTOMER THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE ANCHOR BENT AND SUTURE BREAK WERE DUE TO THE PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE OR WERE RELATED TO A DEVICE MALFUNCTION. CAUSE NOT ESTABLISHED IS SELECTED AS THE MOST PROBABLE CAUSE FOR THIS EVENT. FOR THE EVENTS ADDITIONAL DEVICE REQUIRED, INADEQUATE/INAPPROPRIATE TREATMENT OR DIAGNOSTIC EXPOSURE, AND ADDITIONAL SURGERY, IT HAPPENED DURING THE PROCEDURE, AND THE MOST PROBABLE CAUSE OF THIS REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. FOR THIS REASON, THEY WILL BE CLASSIFIED AS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A FISTULA REPAIR ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT. UPON REMOVAL OF THE FIRST OVERSTITCH DEVICE, IT WAS OBSERVED THERE WAS TISSUE DAMAGE TO THE ESOPHAGUS, WHICH CAUSED MAJOR BLEEDING. THE BLEEDING WAS TREATED WITH PURASTAT. AN ATTEMPT WAS MADE TO COMPLETE THE PROCEDURE WITH A SECOND OVERSTITCH DEVICE, WHICH WAS ALSO BENT. THE SECOND OVERSTITCH DEVICE DID NOT CAUSE ANY COMPLICATIONS. THE PHYSICIAN ATTEMPTED TO CLOSE THE FISTULA USING CLIPS. HOWEVER, THE CLIPS WERE NOT SUCCESSFUL. THE PATIENT HAD AN ADDITIONAL SURGERY TO SUCCESSFULLY CLOSE THE FISTULA. THE PATIENT HAS MADE A FULL RECOVERY. THIS REPORT IS RELATED TO THE SECOND OF TWO OVERSTITCH SUTURES AND TWO OVERSTITCH DEVICES USED IN THE SAME PROCEDURE. PLEASE REFER TO REPORTS 3005099803-2025-06116 FOR THE FIRST OVERSTITCH DEVICE, 3005099803-2025-06280 FOR THE FIRST OVERSTITCH SUTURE, AND 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A FISTULA REPAIR ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT. UPON REMOVAL OF THE FIRST OVERSTITCH DEVICE, IT WAS OBSERVED THERE WAS TISSUE DAMAGE TO THE ESOPHAGUS, WHICH CAUSED MAJOR BLEEDING. THE BLEEDING WAS TREATED WITH PURASTAT. AN ATTEMPT WAS MADE TO COMPLETE THE PROCEDURE WITH A SECOND OVERSTITCH DEVICE, WHICH WAS ALSO BENT. THE SECOND OVERSTITCH DEVICE DID NOT CAUSE ANY COMPLICATIONS. THE PHYSICIAN ATTEMPTED TO CLOSE THE FISTULA USING CLIPS. HOWEVER, THE CLIPS WERE NOT SUCCESSFUL. THE PATIENT HAD AN ADDITIONAL SURGERY TO SUCCESSFULLY CLOSE THE FISTULA. THE PATIENT HAS MADE A FULL RECOVERY. THIS REPORT IS RELATED TO THE SECOND OF TWO OVERSTITCH SUTURES AND TWO OVERSTITCH DEVICES USED IN THE SAME PROCEDURE. PLEASE REFER TO REPORTS 3005099803-2025-06116 FOR THE FIRST OVERSTITCH DEVICE, 3005099803-2025-06280 FOR THE FIRST OVERSTITCH SUTURE, AND 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532158 OVERSTITCH 2-0 POLYPROPYLENE SUTURE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY UNK-P-OVERSTITCH_SUTURE 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention