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

Model Number	13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Gastrointestinal Problem (4491)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case does not come from either device malfunction or user error.It is a possible complication in the post-interventional interval.The risk of local infection and also appendicitis is covered in the clinical literature and is part of our user information.Note : this report is part of the subsequent notification, as communicated by ovesco on 24.10.2024 and refers to: follow up questions ftrd system perforation-clip detached failure_10-03-2024 annex 1.
Event or Problem Description
A few days after endoscopic resection at the appendiceal orifice with dftrd, the patient developed appendicitis.The appendicits required surgical appendectomy.

• 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: 20693047
• Report Number: 3006696607-2024-00023
• Device Sequence Number: 15599405
• Product Code: PKL
• UDI-Device Identifier: 04260206311072
• UDI-Public: 04260206311072
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 09/20/2025
• Device Model Number: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 843540
• 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: 11/07/2023
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG