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	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Cftrd was performed for an early carcinoma located at the left flexure.During clip deployment, the handwheel was turned, however, it was only assumed that the clip had not been deployed, although tissue resection had occurred.A resulting perforation was surgically closed and the rest of the course of the illness proceeded without complications.
Additional Manufacturer Narrative
The device was discarded and therefore not available for technical analysis.The review of manufacturing related documentation did not reveal any indications of possible deviations from the product specifications.As reported, electrical resection was initiated without visual confirmation of complete clip application.The instructions for use state that the application ring must be visualized during clip application and must be monitored to ensure safe clip placement.The risk of causing a perforation is indicated in the ifu.Moreover, it is addressed in the user trainings to verify clip application before resection of the target tissue.

• Brand Name: colonic FTRD set
• Common Device Name: colonic FTRD set
• Manufacturer (Section D): Ovesco Endoscopy AG; friederich-miescher strasse 9; tuebingen, baden wuerttemberg 72076 ; GM 72076
• Manufacturer (Section G): Ovesco Endoscopy AG; friederich-miescher strasse 9; tuebingen, baden-wuerttemberg 72076 ; GM 72076
• MDR Report Key: 50787774
• Report Number: 3006696607-2026-00013
• Device Sequence Number: 13154153
• 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): 09/16/2026

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: 867813
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2026
• 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
• Patient Sex: Unknown