MAUDE Adverse Event Report: OVESCO ENDOCOPY AG DIAGNOSTIC FTRD SET; DIAGNOSTIC FTRD SYSTEM SET

Model Number	13
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an intervention in the caecum for eftr, clip deployment was mistakenly assumed while the thread was broken.Correct clip application was not visually controlled, and the target tissue was subsequent resected.The resulting perforation was closed with 7 tts clip.The patient was admitted overnight and did well without any complications.
Additional Manufacturer Narrative
The microscopic examination showed thread was torn appr.170 cm from the distal end.Due to the present damage pattern, it is possible that the thread was jammed between handwheel adapter and the endoscope port.When turning the handwheel, the thread tension increase up to breakage, thereby the clip cannot be moved forward and remained on the cap.The review of the related quality records of the manufacturing lot showed no abnormalities.In conclusion, the failure root cause is seen as a procedural complication due to non-deployment of the clip before snaring in the sense of a use-sequence error.The risk of causing a perforation is listed in the instructions for use.It is addressed in the user trainings, to verify successful clip application before resection of the target tissue.Note: this report is a retrospective submission of complaints from the year 2024.

• Brand Name: DIAGNOSTIC FTRD SET
• Common Device Name: DIAGNOSTIC FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, baden württemberg 72076 ; GM 72076
• MDR Report Key: 22017630
• Report Number: 3006696607-2025-00032
• Device Sequence Number: 9504782
• Product Code: PKL
• UDI-Device Identifier: 04260206311072
• UDI-Public: 4260206311072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 05/24/2024
• Device Model Number: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 834867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG