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	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dftrd was used to remove a polyp in the cecum.After turning the handwheel, the application ring moved past visualization due to a large amount of tissue in the cap.Therefore clip application was not visually verified before the tissue was resected.Assuming successful clip application, the resection took place.Many loops or twist of the endoscope, like in the cecum, can reduce force transmission.In such cases, it is necessary to turn the handwheel with increased force to reliably deploy the clip.In the present case, the view of the application ring was limited, so it was not noticed that the clip had not been fully advanced from the cap.After removal of the endoscope, the clip could finally be released by further turning the handwheel.This indicates that insufficient force was applied during clip deployment.The review of the manufacturing-related documentation did not reveal any deviations.A manufacturing-related error can be therefore excluded with high probability.It is stated in the instructions of use, that the application ring must remain visible in the endoscopic image and must be observed.Only when the application ring has moved fully forwards to the edge of the cap, the clip has been deployed.
Event or Problem Description
The dftrd was used to remove a polyp in the cecum.After turning the handwheel, the application ring moved past visualization due to a large amount of tissue in the cap.Assuming successful clip application, the resection took place.The resulting perforation was closed with clips within the same procedure.Due to suspected peritonitis, the patient was sent for surgery.

• 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: 24142053
• Report Number: 3006696607-2026-00001
• Device Sequence Number: 9357036
• Product Code: PKL
• UDI-Device Identifier: 04260206311072
• UDI-Public: 04260206311072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/22/2026

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: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 863672
• 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: 01/09/2026
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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: Required Intervention
• Patient Sex: Unknown