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	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The colonic ftrd was used for the removal of a lesion in the ascending colon in a hybrid approach of emr followed by full thickness resection with ftrd.Assuming clip application, the resection was performed.Subsequently, incomplete clip deployment and perforation were found.The perforation was closed with conventional endoscopic clips in the same procedure and not other interventions were needed.
Additional Manufacturer Narrative
The colonicftrd was intended to be used for the removal of a lesion in the ascending colon.The returned product components, comprising the electrical snare, the clip release thread, the application cap and clip deployment ring, were technically examined.The clip was missing.No visible damage or abnormality was identified.Functional simulation using an off the shelf ftrd clip, demonstrated clip release without any problem.As reported, electrical resection was initiated without visual confirmation of complete clip application.The instructions for use state that the application ring must be visualised during clip application and must be monitored to ensure safe clip placement.A review of the production-related documentation revealed no abnormalities.The investigation therefore found no evidence of a product or manufacturing-related defect.

• 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: 50201924
• Report Number: 3006696607-2026-00010
• Device Sequence Number: 16061491
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/11/2026

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: 864182
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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: Required Intervention
• Patient Sex: Unknown