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

Model Number	FTRD 13
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Achalasia (1692); Perforation of Esophagus (2399)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient suffered a lower esophageal/ge-junction perforation.Dilatation twas necessary to reach the gastric cavity with gdftrd.Perforation is a known complication in dilatation of achalasia stenosis.The review of the lot based quality records revealed no abnormalities an production related device defect can be excluded with very high probability.In conclusion the adverse event is related to a procedural complication and is not device related.Note: this report is part of 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 a planned resection of a lesion in the duodenum.To access the duodenum a dilatation of an esophageal narrowing was required, during which an esophageal perforation occurred.The patient suffered from achalasia.The perforation was closed by surgery.

• Brand Name: GASTRODUODENAL FTRD SET
• Common Device Name: GASTRODUODUNAL FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• MDR Report Key: 20693116
• Report Number: 3006696607-2024-00020
• Device Sequence Number: 20964641
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 01/17/2025
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 841593
• 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: 04/11/2023
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2022
• 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 Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG