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	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The claimed product was technically analyzed.Upon arrival, the clip was still on the cap and had only moved forward slightly.The cap and clip showed no abnormalities that could indicate difficult clip application.During the technical examination, the clip was easily deployed.There were also no abnormalities on the application ring indicating difficulty.The thread was wrapped around the snare shaft and pulled very tight, which most likely reduced the force exerted on the ring.A review of the production-related documentation revealed no abnormalities.A manufacturing-related defect can therefore be excluded with high probability.User reports stated that the view of the ring was obstructed by the amount of tissue mobilized into the cap.The instructions for use state that the ring must remain visible and be observed during clip deployment.This was not the case here due to tissue in the cap.Furthermore, it was not verified whether the clip had been successfully deployed before resection.
Event or Problem Description
The cftrd was used for a full-thickness resection following emr to remove a high-grade adenoma.Assuming successful clip application, the resection was performed.Subsequently, non-deployment of the clip was detected.The resulting perforation was closed with a clip and sutures during the same procedure.

• Brand Name: COLONIC FTRD SET
• Common Device Name: COLONIC FTRD SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tübingen, baden-wuerttemberg 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; baden-wuerttemberg 72076 ; GM 72076
• Manufacturer Contact: friedrich-miescher-str. 9; tübingen, baden-wuerttemberg 72076
• MDR Report Key: 25315520
• Report Number: 3006696607-2026-00007
• Device Sequence Number: 9985825
• 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): 05/28/2026

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: 857454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown