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	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The technical analysis of the affected cftrd led to the following results: all device components were in accordance with their specifications.The functional test revealed clip deployment without any problems.The review of the lot based production quality records did not reveal any abnormalities, meaning that a manufacturing error can be ruled out.In summary, the cause of the error is not device related but can be attributed to a procedural complication.Bowel perforation is a known procedural complication in the resection of colon lesions.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.
Event or Problem Description
During an intervention in the recto sigmoid for eftrd, clip deployment was mistakenly assumed and not visually verified prior to resection of the target tissue.The resulting superficial perforation was closed with 4 mantis clip.The patient recovered without any further treatment.

• 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: 22017651
• Report Number: 3006696607-2025-00043
• Device Sequence Number: 9484783
• Product Code: PKL
• UDI-Device Identifier: 04260206311072
• UDI-Public: 4260206311072
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 06/03/2026
• Device Model Number: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 851164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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