MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG COLONIC FTRD SET; COLONIC FTRD SYSTEM SET

Model Number	14
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the colonic ftrd was used for the treatment of an adenoma in the appendix area.Due to a large amount of tissue in the cap, the view of the white application ring was restricted and the successful clip application was therefore not verified before tissue resection.The resulting perforation was closed with clips within the same procedure.The patient stayed in icu overnight and recovered well.
Additional Manufacturer Narrative
The device in question was returned for technical analysis.Upon arrival the clip was slightly advanced on one side of the cap.During technical analysis, the clip could be applied without any problems.Both the cap and the clip were within the product specifications.No indications of a product malfunction could be detected.Due to the location of the treatment it cannot be ruled out, that high counter-pressure was applied on the clip resulting in a more difficult clip application.It was reported that the view of the application ring was limited due to the large amount of tissue in the cap.It is the responsibility of the user to verify successful clip application prior to tissue resection.As stated in the instruction of use, the white application ring must be 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.If the clip application is not verified prior to tissue resection, a perforation can occur.The risk of causing a perforation is indicated in the instruction of use.Moreover, it is addressed in the user trainings to verify successful clip application before resection of target tissue.Note: this report is a retrospective submission of complaints from the year 2021.

• Brand Name: COLONIC FTRD SET
• Common Device Name: COLONIC FTRD SYSTEM 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: 22025529
• Report Number: 3006696607-2025-00011
• Device Sequence Number: 17951406
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 03/31/2023
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 823319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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; Hospitalization
• Patient Sex: Unknown