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	Internal Organ Perforation (1987)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device was discarded and therefore not available for technical analysis.The pictures of the device after procedure show that the clip was not on the cap and that the white application ring has moved forward to the edge of the cap.This indicates that there was no problem with the application mechanism.As the user reported that the clip was not applied to the target tissue, it can be assumed that the clip fell off in the stomach.Clip application at the target site was not verified by the user prior to tissue resection.No indication of a product malfunction or a deviation from product specification can be found.When the clip application is not verified prior to tissue resection, a perforation can occur.As stated in the instruction of use, the clip application must be verified by the user before tissue resection.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.
Event or Problem Description
It was reported that the gastroduodenal ftrd was used to treat a gist in the stomach.Successful clip application was not verified prior to tissue resection.The resulting perforation was closed with clips within the same procedure.The patient stayed in hospital overnight and recovered well.

• 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, 72076 ; GM 72076
• MDR Report Key: 22025495
• Report Number: 3006696607-2025-00007
• Device Sequence Number: 7266718
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/14/2025

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: 02/02/2023
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 829883
• 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: 07/13/2021
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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: Hospitalization; Other
• Patient Sex: Unknown