MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OverStitch Endoscopic Suture System; Endoscopic Tissue Approximation Device

Model Number	M00505410
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an esophagogastroduodenoscopy (egd) stent fixation procedure on (b)(6) 2026.Prior to the procedure, it was noticed that the sterile package seal was damaged upon opening the device box.The procedure was completed with a new overstitch device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a020503 is being used to capture the reportable event of seal compromised.Block h11: device evaluation: the overstitch ess was not returned for evaluation, and no media was available for analysis.The reported event could not be confirmed.Product analysis could not be performed, for this reason and due to the lack of evidence the reported event is unable to be confirmed.A risk review of the overstitch ess was completed and confirmed that the event of packaging seal compromised was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.A labeling review was performed.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.Based on all gathered information, there is not enough evidence to determine whether the packaging seal compromised was due to the physician's technique during the device preparation, transport, storage or was related to a device malfunction.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.All compiled information on this investigation determines that the most probable cause is cause not established.

• 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 ; +1(914)571-6918
• MDR Report Key: 50320607
• Report Number: 3005099803-2026-03399
• Device Sequence Number: 15951055
• Product Code: OCW
• UDI-Device Identifier: 00191506060091
• UDI-Public: (01)00191506060091(17)290107(10)38299437
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 0038299437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 01/08/2026
• 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