MAUDE Adverse Event Report: OVESCO ENDOCOPY AG COLONIC FTRD SET; COLONIC FTRD SYSTEM SET

Model Number	14
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an intervention with cftrd for full tissue resection in the caecum, clip deployment was not verified by the operator before tissue resection.The resulting perforation required closure with one 14/6 otsc clip.The patient recovered without any further treatment.
Additional Manufacturer Narrative
During colonic full-thickness resection handwheel rotation reportedly required increased force.The technical analysis revealed a blocked release thread due to wrong set up onto the endoscope.Therefore force transition to the clip was restricted.The observation of the clip release is mandated in the instructions for use and refers to the risk of bowel perforation as a possible procedural complication during resection of colonic lesions.During the technical analysis, the device complied with the specifications.The review of the production quality records did not reveal any anomalies that would indicate a product-related defect.

• Brand Name: COLONIC FTRD SET
• Common Device Name: COLONIC FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, baden württemberg 72076 ; GM 72076
• MDR Report Key: 22058412
• Report Number: 3006696607-2025-00050
• Device Sequence Number: 20742888
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 4260206311010
• 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): 05/21/2025

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 Expiration Date: 10/03/2026
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 856500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG