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	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected product was technically analysed.Upon arrival, the clip was still on the cap and was only slightly moved forwards.The thread showed some crushing and flattening.This indicates that the grasper used was wrapped around the thread when inserted into the endoscope working channel.Turning the hand wheel caused the thread to be crushed.The force transmission was significantly reduced by the wrapped grasper, which can make clip application more difficult.During technical analysis, the clip could be applied without any problems.There are no indications of a product malfunction.The clip application was not verified by the user prior to tissue resection.It is stated in the instructions of use, that the application ring must remain visible and be observed.Only when the application ring has moved fully forwards to the edge of the cap the clip has been applied.The risk of causing a perforation is indicated in the instructions of use.Moreover, it is addressed in the user trainings to verify successful clip application before resection of target tissue.
Event or Problem Description
The colonic ftrd was used for the treatment of an adenoma in the hepatic flexure.After turning the handwheel, the clip was not applied and the tissue was resected.The resulting perforation was closed with a clip within the same procedure.The patient was hospitalized for monitoring and 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: 22735501
• Report Number: 3006696607-2025-00055
• Device Sequence Number: 13041784
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: 858818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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