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	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned for technical analysis.Upon arrival the clip was still on the cap and was slightly moved forward.During technical analysis the clip could be applied without any problems.All components were inspected and no deviation from product specification could be detected.Due to the large amount of tissue mobilized into the cap, the view of the white application ring was limited.Additionally, the large amount of tissue possibly caused an increased counterpressure on the target tissue, which, together with the anatomically determined, curved endoscope, led to the increased thread tension described.Due to the resulting haptic impression on the hand wheel, the user incorrectly assumed that the clip had already been deployed when he performed the resection.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 to treat an adenoma in the right flexure.The user turned the hand wheel and due to the resulting haptic impression on the handwheel, the user mistakenly assumed that the clip had already been deployed when he performed the resection.The resulting perforation was closed with a clip within the same procedure.

• 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: 22025551
• Report Number: 3006696607-2025-00024
• Device Sequence Number: 21113494
• 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: 05/27/2025
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 843943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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