BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERSTITCH 2-0 POLYPROPYLENE SUTURE

    MDR report key: 23623537 · Received November 21, 2025

    Report

    Report Number
    3005099803-2025-06280
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 13, 2026
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    PMA / PMN Number
    K181141
    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. IMDRF CODE E0506 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HEMORRHAGE, MAJOR.

    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. IMDRF CODE E0506 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HEMORRHAGE, MAJOR. DEVICE EVALUATION: BLOCK H11: THE DEVICE DID NOT RETURN FOR ANALYSIS HOWEVER THE CUSTOMER PROVIDED SOME PICTURES. A MEDIA INSPECTION WAS PERFORMED, WHERE IT IS POSSIBLE TO IDENTIFY THE ANCHOR OF THE OVERSTITCH SUTURE BENT INTO THE NEEDLE OF OVERSTITCH. ADDITIONALLY, A SHORT PIECE OF A BROKEN SUTURE CAN BE SEEN. 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 WAS DUE TO THE PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE OR WAS 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, WILL BE CLASSIFIED AS CAUSE NOT ESTABLISHED. IN ACCORDANCE WITH THE CUSTOMER'S EVENT DESCRIPTION AND INFORMATION PROVIDED, FOR THE EVENTS HEMORRHAGE, MAJOR AND TISSUE THESE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. FOR THIS REASON, THE EVENT IS CATALOGUED AS "KNOWN INHERENT RISK OF DEVICE" BECAUSE THE REPORTED ADVERSE EVENT KNOWN AND DOCUMENTED IN THE LABELING (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS). THERE IS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION.

    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 FIRST 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, 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE, AND 3005099803-2025-06281 FOR THE SECOND OVERSTITCH SUTURE.

    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 OCTOBER 17, 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 FIRST 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, 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE, AND 3005099803-2025-06281 FOR THE SECOND OVERSTITCH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024511 OVERSTITCH 2-0 POLYPROPYLENE SUTURE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY UNK-P-OVERSTITCH_SUTURE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention