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	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was only partly returned.The components essential for technical analysis were not returned.According to the information provided by the user the thread ruptured during procedure but this was not noticed.In the following the clip was not applied and the tissue resected.The clip application was not verified by observing the application ring by the user.It is possible that the thread was damaged when the grasping device was inserted through the working channel of the endoscope.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 to treat a net in the rectum.During procedure the thread ruptured but this was not noticed.Due to a large amount of tissue in the cap the white application ring was not observed.Clip application was not verified before tissue resection.The resulting perforation was closed within the same procedure with clips.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: 22606998
• Report Number: 3006696607-2025-00054
• Device Sequence Number: 10107021
• 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): 07/21/2025

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 Expiration Date: 10/02/2025
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 846232
• 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: 07/07/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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