MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG GASTRODUODENAL FTRD SET; GASTRODUODENAL FTRD SYSTEM SET

Model Number	FTRD 13
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the gastroduodenal ftrd was used for the treatment of a net in the duodenum.Clip application was not verified prior to tissue resection.The resulting perforation was closed with clips within the same procedure.No further information on the patient´s state of health is available.
Additional Manufacturer Narrative
The device in question was returned to ovesco for technical analysis.Upon arrival the clip was still on the cap.The clip was slightly advanced on one side.During technical analysis the clip could be applied with normal force.All components were inspected and no deviation from product specification could be found.No product malfunction could be detected.In regard to the localization of the treatment, it cannot be excluded that high counterpressure towards the clip was applied.In this case more force may be needed to apply the clip successfully.It is stated in the instruction of use that the white application ring must be remain visible and be observed.Only when the white application ring has moved fully forwards to the edge of the cap the clip has been applied.If the clip application is not verified prior to tissue resection, a perforation can occur.The risk of causing a perforation is indicated in the instruction of use.Moreover, it is addressed in the user trainings to verify successful clip application before resection of target tissue.Note: this report is a retrospective submission of complaints from the year 2021.

• Brand Name: GASTRODUODENAL FTRD SET
• Common Device Name: GASTRODUODENAL FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, baden-wuerttemberg 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, baden-wuerttemberg 72076 ; GM 72076
• MDR Report Key: 21662028
• Report Number: 3006696607-2025-00005
• Device Sequence Number: 15637684
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200684
• 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): 03/21/2025

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: 07/12/2022
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 825275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• 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