MAUDE Adverse Event Report: OVESCO ENDOCOPY 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	Internal Organ Perforation (1987)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an intervention in the upper gi tract for eftr, clip deployment was not visually verified before performing resection.The resulting perforation was closed with otsc.The patient recovered without further treatment.
Additional Manufacturer Narrative
Since the affected device was discarded, no technical evaluation was possible, and the analysis is based on the information provided by the user.The clip release was not optically verified before executing the snare resection.Such observation of clip release is mandated by the device's ifu.Perforation is a known procedural complication in the resection of lesions.The inspection of the production quality records showed no abnormalities that indicate a product-related defect.Note: this report is a retrospective submission of complaints from the year 2024.

• Brand Name: GASTRODUODENAL FTRD SET
• Common Device Name: GASTRODUODENAL 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: 22017622
• Report Number: 3006696607-2025-00034
• Device Sequence Number: 9446917
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 4260206310655
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 01/09/2026
• Device Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: 847807
• 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: 02/09/2024
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG