MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG COLONIC FTRD SET

Model Number	14
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Fire (2610)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device was discarded by the hospital and was not available for technical analysis.The cftrd was used to treat an adenoma in the colon ascendens.The clip was not deployed before tissue resection.The outer diameter of the endoscope used for the procedure is too small and therefore does not comply with the specifications mentioned in the instructions for use.This can lead to difficulties with clip deployment.According to the information provided by the user, a grasping instrument and suction was used to mobilize the tissue and during clip deployment.This can cause high tissue counterpressure making clip application more difficult.It is stated in the instruction for use that the tissue must not be sucked into the application cap, but must be collected.Additionally, the instruction for use states that the application ring must be remain visible and be observed in the endoscopic image.Clip application must be verified before tissue resection otherwise this can result in a perforation.The review of the manufacturing-related documentation did not reveal indications of a product malfunction or a deviation from product specification.
Event or Problem Description
The colonic ftrd was used for the treatment of an adenoma in the ascending colon.The clip was not deployed before resecting the tissue.The resulting perforation was closed with clips within the same prodedure.The patient recovered well.

• 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: 23509833
• Report Number: 3006696607-2025-00058
• Device Sequence Number: 21278515
• 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): 11/10/2025

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: 862059
• 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: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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