MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG GASTRODUODENAL FTRD SET

Model Number	FTRD 13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was discarded and therefore not available for technical analysis.Tissue mobilization was described by the user as extremely difficult due to the fibrotic target tissue.The clip was deployed but the tissue was accidentally resected not above the clip.If the tissue is not firmly secured, the endoscope tip can be detached from the target tissue due to peristaltic movements.This is a rare procedural complication and is not related to a product malfunction.It is stated in the instruction for use that during clip application the tissue must be kept under slight tension by using a grasping device until resection is complete.This keeps the tissue and endoscope tip in position.This prevents accidental resection at an undesired site due to the instrument slipping.Note: this report is a retrospective submission of complaints from the year 2023.
Event or Problem Description
It was reported that the gastroduodenal ftrd was used to treat a fibrotic lesion in the stomach.The clip was successful deployed.The tissue was accidentally resected at a different site.The resulting perforation was immediately detected and closed with clips.

• Brand Name: GASTRODUODENAL FTRD SET
• Common Device Name: GASTRODUODENAL FTRD SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tuebingen, 72076 ; GM 72076
• MDR Report Key: 22025519
• Report Number: 3006696607-2025-00027
• Device Sequence Number: 12572197
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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 Model Number: FTRD 13
• Device Catalogue Number: 200.72
• Device Lot Number: UNKNOWN
• 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: 08/03/2023
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown