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	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device was discarded and therefore not available for technical analysis.The analysis of the production related documentation did not reveal any deviations.The one-sided forward movement of the application ring was misinterpreted by the user as clip application.It is stated in the instruction of use that 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.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 2023.
Event or Problem Description
It was reported that the colonic ftrd was used for the treatment of a lesion in the transverse colon.Due to a large amount of tissue mobilized into the cap, the view of the white application ring was limited.After turning the hand wheel, the application ring moved slightly forward.This was misinterpreted as successful clip application.The tissue was resected subsequently and a perforation occurred.The perforation was closed with clips within the same procedure.The patient was discharged from hospital the following day.

• 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: 22025508
• Report Number: 3006696607-2025-00023
• Device Sequence Number: 17919442
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 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: 08/10/2024
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 836586
• 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: 03/10/2023
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2021
• 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
• Patient Sex: Unknown