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

Model Number	FTRD 13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that gastroduodenal ftrd was successfully used for a treatment in the stomach.After a few day the patient developed abdominal pain and it was discovered that the clip had detached from resection site.Patient underwent surgery.The product was discarded by the hospital and therefore no technical analysis was performed.The gastroduodenal ftrd treatment was conducted without complications, there was no technical failure of the device.This case does not come from either device malfunction or user error.It is a possible complication in the post-interventional interval.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
It was reported that initial gastroduodenal ftrd treatment in the stomach was successful and without complications.After a few days the patient had developed abdominal pain.The ftrd clip had detached from resection site and patient needed surgery.

• 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: 20878349
• Report Number: 3006696607-2024-00035
• Device Sequence Number: 20784736
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 4260206310655
• 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): 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: 04/20/2024
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 830571
• 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: 07/06/2021
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• 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; Required Intervention
• Patient Sex: Unknown