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	Perforation (2001)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was not available for technical analysis.The gdftrd was used for the treatment of a lesion in the stomach.After one week the clip fell off the tissue, resulting in a perforation.The initial treatment was successful, there are no indications of a device failure.On the picture provided, the clip appears to be in good position.This case can be considered a postprocedural, clinical complication.In rare cases the clip may detach before healing.The risk of subsequent clip detachment is mentioned in both the instructions for use and in our training courses.
Event or Problem Description
The gastroduodenal ftrd was used for the treatment of a lesion in the stomach.The initial treatment was successful; the clip was applied as intended.After one week it was noticed that the clip had subsequently fallen off the tissue.The resulting perforation was closed by a wedge treatment.

• 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: 22370249
• Report Number: 3006696607-2025-00052
• Device Sequence Number: 20839377
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 06/25/2025
• Initial Report FDA Received Date: 07/01/2025
• 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