MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG COLONIC FTRD SET

Model Number	14
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cftrd was used for the resection of a lesion in the area of the ileocecal valve.During clip application, it was observed that the application ring moved slightly forward.Due to the amount of tissue in the cap, full visibility of the application ring was restricted.It was assumed that the clip had been applied, and the tissue was subsequently resected.Upon review, it was found that the clip had only moved forward on one side of the cap.Possible causes for this include multiple loops of the endoscope, which can impair force transmission to the thread, or strong unilateral tissue resistance.This can lead to partial advancement of the clip without actual application to the tissue.The review of the manufacturing-related documentation did not reveal any deviations from product specifications.It is stated in the instructions for use that the application ring must remain visible in the endoscopic image and be observed.Only when the application ring has moved fully forwards to the edge of the cap, the clip has been applied.
Event or Problem Description
The colonic ftrd was used for the resection of a lesion in the area of the ileocecal valve.During clip application, it was observed that the application ring moved slightly forward.Due to the amount of tissue in the cap, full visibility of the application ring was restricted.It was assumed that the clip had been applied, and the tissue was subsequently resected.The resulting perforation was closed with clips and suture.
Additional Manufacturer Narrative
This report is related to the user´s voluntary report (report nr.Mw5184085).

• Brand Name: COLONIC FTRD SET
• Common Device Name: COLONIC FTRD SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, 72076 ; GM 72076
• Manufacturer Contact: friedrich-miescher-str. 9; tuebingen, 72076
• MDR Report Key: 24428363
• Report Number: 3006696607-2026-00003
• Device Sequence Number: 8132704
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2026
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 854142
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown