MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG DIAGNOSTIC FTRD SET

Model Number	13
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the diagnostic ftrd was used to treat an adenoma in the appendiceal orifice.Due to a large amount of tissue mobilized into the cap, the view of the white application ring was limited.After turning the hand wheel the successful clip application was not verified prior to tissue resection.The resulting perforation was closed with a clip within the same procedure.
Additional Manufacturer Narrative
The device in question was partially returned for technical analysis.The hand wheel was not returned.Upon arrival the clip was still on the cap and slightly advanced on one side.During technical analysis the clip could be applied without any problems.All available components were inspected and no deviation from product specification could be detected.Due to localisation, the endoscope was coiled during the procedure, which may have limited force transmission to the clip and affected the haptic impression when turning the handwheel (increased force).In addition, the cap was completely filled with tissue, which limited the view of the white application ring during its forward movement, leading to the mistaken assumption that clip application had occurred.The failure was caused by a procedural complication and was not device related.It is stated in the instruction of use that the white application ring must be remain visible and be observed.Only when the white application ring has moved fully forwards to the edge of the cap the clip has been applied.The risk of causing a perforation is indicated in the instruction of use.Moreover, it is addressed in the user trainings to verify successful clip application before resection of target tissue.Note: this report is a retrospective submission of complaints from the year 2023.

• Brand Name: DIAGNOSTIC FTRD SET
• Common Device Name: DIAGNOSTIC 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: 22025339
• Report Number: 3006696607-2025-00022
• Device Sequence Number: 9390693
• Product Code: PKL
• UDI-Device Identifier: 04260206311072
• UDI-Public: 04260206311072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170867
• 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: 10/24/2024
• Device Model Number: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 837864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: Other
• Patient Sex: Unknown