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)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The cftrd was used to treat a rectal lesion.A large amount of tissue was mobilized into the cap and the application ring was not observed.After turning the handwheel, the user assumed clip application without visual control.The clip was not deployed but tissue was resected.The resulting perforation was closed by surgery.The patient recovered well.
Additional Manufacturer Narrative
The device was discarded and therefore not available for technical analysis.The tissue mobilization was described as difficult due to pre-resected and scarred tissue.It cannot be excluded that high counterpressure against the clip was applied.In this case more force may be needed to deploy the clip.The review of the manufacturing related documentation did not reveal any indications of possible deviations from product specifications.It was reported that after turning the handwheel, the application ring was not observed and the user assumed clip application without visual control.It is stated in the instructions for use that the application ring must be remain visible and be observed.Only when the 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 instructions of use.Moreover, it is addressed in the user trainings to verify successful clip application before resection of target tissue.

• Brand Name: COLONIC FTRD SET
• Common Device Name: COLONIC FTRD 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: 23013392
• Report Number: 3006696607-2025-00056
• Device Sequence Number: 9539243
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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 Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 861597
• 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: 09/02/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• 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