MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OVERSTITCH ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	M00505410
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h3 the device was received by boston scientific on (b)(6) 2026.Product investigation is ongoing, and a supplemental report will be submitted to communicate the results.Block h6: device code a0501 is being used to capture the reportable event of cap detachment.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026.During preparation for the procedure, it was noted by the physician that the alignment tube was detached from the endcap of the device.An alternative overstitch handle was utilized to proceed with the procedure.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25222645
• Report Number: 3005099803-2026-01972
• Device Sequence Number: 9973666
• Product Code: OCW
• UDI-Device Identifier: 00191506060091
• UDI-Public: (01)00191506060091(17)290217(10)38632121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00505410
• Device Catalogue Number: M00505410
• Device Lot Number: 0038632121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown