MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG GASTRODUODENAL FTRD SET

Model Number	FTRD 13
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Fire (2610)
Health Effect - Clinical Code	Stomach Ulceration (4488)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was not available for technical analysis.The gdftrd was used to remove a stomach lesion.Tissue mobilised with a grasper restricted the view.As the application ring was not observed, the user possibly assumed that the clip had been deployed and resected the tissue.It is stated in the instruction for use that clip application must be verified before tissue resection.The application ring must remain visible and be observed in the endoscopic image.Only when the application ring has moved fully forwards to the edge of the cap, the clip has been applied.
Event or Problem Description
The gastroduodenal ftrd was used to remove a stomach lesion.The clip was not deployed and the tissue was resected.No full thickness resection was performed and the mucosal lesion was closed with clips.No further clinical intervention was needed.

• 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: 23539763
• Report Number: 3006696607-2025-00059
• Device Sequence Number: 13082403
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/13/2025

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: 860144
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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