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	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The colonic ftrd was used to treat a lesion in the colon ascendens.Due to the large amount of tissue in the cap, the application ring could not be seen.After turning the hand wheel, the clip application was assumed and the tissue was resected.During technical analysis the clip could be deployed without any problems.No malfunctions of the device or deviations from product specifications were found.As can be seen in the pictures provided by the user, the ftrd clip did not move on the cap.It was reported that suction was used during clip application.This can result in high tissue counterpressure, requiring more force to apply the clip.As the application ring was not observed, the clip non-deployment was not detected by the user.The review of the manufacturing-related documentation did not reveal any deviations.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 to treat a lesion in the colon ascendens.The clip was not deployed and the tissue was resected.The resulting perforation was closed with an otsc clip within the same procedure.The patient recovered well.

• 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
• MDR Report Key: 24738541
• Report Number: 3006696607-2026-00005
• Device Sequence Number: 15763533
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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 Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 863321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: Other
• Patient Sex: Unknown