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 Codes	Laceration(s) of Esophagus (2398); Bowel Perforation (2668)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the diagnostic ftrd was used to treat a lesion in the duodenum.Clip application was not verified before tissue resection.The resulting perforation was closed with a clip.This clip had to be removed due to incomplete perforation closure.During endoscope retraction and clip removal, the patient´s esophagus was accidentally injured by the clip.The bowel perforation was closed with overstitching and another clip.The esophageal tear was then closed with endoclips.The patient stayed in hospital overnight and scans were scheduled for the following day.
Additional Manufacturer Narrative
The device in question was partially returned.Hand wheel and clip were not returned.The remaining components were inspected and no deviation from product specification could be detected.Due to the localization of the target tissue, the endoscope must be wound several times for anatomical reasons.This can result in a limited force transmission to the clip.Due to a large amount of tissue mobilized into the cap, the view of the application ring was limited.The user assumed successful clip application without verification beforehand and performed the resection.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 2022.

• 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: 22024220
• Report Number: 3006696607-2025-00018
• Device Sequence Number: 9099602
• 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: 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: 05/31/2023
• Device Model Number: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 828491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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: Hospitalization; Other
• Patient Sex: Unknown