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	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was technically analysed.No deviations from product specifications were found.Both the clip and the cap are within specification and show no signs, that could indicate difficult clip application.The user mistakenly assumed clip application after turning the hand wheel and resected the tissue without verifying this by observing the application ring.It is stated in the instructions of use that the white application ring must remain visible and be observed.Only when the white application ring has moved fully forwards to the edge of the cap the clip has been applied.The risk of causing a perforation is indicated in the instructions of use.Moreover, it is addressed in the user trainings to verify successful clip application before resection of target tissue.
Event or Problem Description
The colonic ftrd was used for the treatment of a neuroendocrine tumor in the rectum.The clip application was not verified prior to tissue resection due to a large amount of tissue and blood in the cap.The resulting perforation was closed with an overstitch device within the same procedure.No additional treatment was necessary and 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: 22466431
• Report Number: 3006696607-2025-00053
• Device Sequence Number: 4272212
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/10/2025

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: 857454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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