MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG GASTRODUODENAL FTRD SET

Model Number	FTRD 13
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the gastroduodenal ftrd was used for the treatment of a duodenal net.When attempting to deploy the clip, the monitor froze.The hand wheel was turned until resistance was felt and clip application was assumed, but not visually verified.The tissue was subsequently resected resulting in a perforation.The perforation was closed with multiple clips and a covered stent within the same procedure.The patient stayed in hospital for two weeks.
Additional Manufacturer Narrative
The device in question was discarded by the hospital and therefore not availabe for technical analysis.The review of the production related documentation did not show any indications of a deviation from product specification.The user discribed the tissue mobilization as difficult and reported that the hand wheel was turned until resistance was felt.Due to the localization of the treatment, the endoscope was most likely held in an angled position.Combined with a high tissue counterpressure more force may be required to successfully apply the clip into the target tissue.As stated in the instruction for use the clip deployment must be verified by observing the white application ring.This was not done in this case as the monitor froze when the clip was deployed.Only when the white 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 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 2025.

• Brand Name: GASTRODUODENAL FTRD SET
• Common Device Name: GASTRODUODENAL 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: 22024222
• Report Number: 3006696607-2025-00047
• Device Sequence Number: 13036384
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 04/06/2025
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 845023
• 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: 02/04/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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; Hospitalization
• Patient Sex: Unknown