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

Model Number	M00505410
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040609 is being used to capture the reportable event of needle shaft bent.Block h11 device evaluation the overstitch ess was not returned for evaluation, and there was no media available for analysis.The reported event could not be confirmed.A risk review of the overstitch ess was completed and confirmed that the events of needle shaft bent and additional device required were defined in the risk documentation.These event types have 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 needle shaft bent was due to the physician's technique during the procedure or was related to a device malfunction.For the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.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.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used to treat a fistula in the colon during a flexible sigmoidoscopy procedure on (b)(6) 2026.During the procedure, the needle shaft was bent and could not connect to the anchor.The procedure was completed with a new overstitch device.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 ; +1(914)571-6918
• MDR Report Key: 50050919
• Report Number: 3005099803-2026-03055
• Device Sequence Number: 10628489
• Product Code: OCW
• UDI-Device Identifier: 00191506060091
• UDI-Public: (01)00191506060091(17)290319(10)38886640
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/27/2026

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: 0038886640
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 03/20/2026
• 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