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	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that colonic ftrd was used for the treatment of an ademona at the appendix.Clip application was not verified before tissue resection.The resulting perforation was closed with a clip.
Additional Manufacturer Narrative
The device was discarded and therefore not available for technical analysis.According to the information provided by the user it is highly likely that after turning of the hand wheel it was mistakenly assumed that the clip was deployed although the white application ring was still visible.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.

• 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: 22025536
• Report Number: 3006696607-2025-00021
• Device Sequence Number: 18416828
• 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: 02/03/2025
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 840459
• 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: 02/10/2023
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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