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	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clip application was not verified by the user before tissue resection.The device in question was discarded and therefore no technical analysis could be performed.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.Based on the available information, there is no indication of a technical failure of the device.This report is part of the additional information requested by the fda and the subsequent notification, as communicated by ovesco on 24.10.2024 and refers to: "follow up questions ftrd system perforation-clip detached failure_10-03-2024 annex 1".
Event or Problem Description
Gastroduodenal ftrd was used for the treatment of a carcenoid in the duodenal bulb.Clip application was not visually verified by the user before tissue resection.The resulting perforation was closed by surgery.The patient 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, baden-wuerttemberg 72076 ; GM 72076
• MDR Report Key: 20878344
• Report Number: 3006696607-2024-00030
• Device Sequence Number: 7804352
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 4260206310655
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/09/2024

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: 09/03/2021
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 822703
• 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: 01/13/2021
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown