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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This analysis is based on information provided by the user.The product was discarded and no photos were provided.Manufacturing related documentation for this product charge was reviewed and did not reveal any deviations from product specifications.Full-thickness resection was attempted but the clip was not deployed by handwheel turn.The user informed us that the resection had failed previously in another procedure due to the heavily scarred lesion.Lf the tissue is scarred, more force than usual may be necessary to apply the clip.Instructions for use state that the clip release ring must be observed during clip deployment for visual confirmation before resection.In addition, the use of this instrument enquires mandatory training for the physicians by us as the manufacturer or our designated partners which could not be verified in this case.
Event or Problem Description
Planned full thickness resection (ftrd) of a caecal polyp with dysplasia, involving the appendiceal orifice.The ovesco clip was not deployed following activation of the hand wheel, and a perforation was subsequently identified.The perforation was closed during the procedure.

• Common Device Name: COLONIC FTRD SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, baden-wuerttemberg 72076 ; GM 72076
• Manufacturer Contact: friedrich-miescher-str. 9; tuebingen, baden-wuerttemberg 72076
• MDR Report Key: 25706858
• Report Number: 3006696607-2026-00008
• Device Sequence Number: 14725999
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 862638
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Sex: Unknown