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

Model Number	FTRD 13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	02/27/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Before the ftrd procedure a regular upper gi endoscopy was performed.After the procedure the user did not notice the esophageal perforation.The oesophagus was described as very vulnerable due to long-standing reflux disease.The patient complained about pain after the procedure, but this was not attributed to a possible perforation.There is no indication of a defect of the product or an unusual situation in the ftrd resection procedure itself.In summary, the described error is not attributed to a product malfunction and the user confirmed the regular function of the device.The case represents a procedural complication.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
It was reported that after a successful procedure in the stomach using a gastroduodenal ftrd system set, an esophageal perforation was caused.The perforation went unnoticed, leading to mediastinitis and septic shock, resulting in the patient's death.The perforation was not at the site of the intervention itself; it was in the mid to lower esophagus.At the end of the procedure the endoscopist did not visualize a perforation; the elderly patient had multiple comorbid diseases and in particular chronic reflux and esophagitis with a mechanically vulnerable esophageal wall.

• 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, baden württemberg 72076 ; GM 72076
• MDR Report Key: 20693103
• Report Number: 3006696607-2024-00018
• Device Sequence Number: 8528844
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• 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: 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: 03/07/2023
• 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: Death
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG