MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG COLONIC FTRD SET; COLONIC FTRD SYSTEM SET

Model Number	14
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was partially returned and analysed.The clip was not available for investigation.Slight indentations can be seen on the cap most likely caused by the one-sided clip movement.The hand wheel shows signs of non-axial rotation movements and that excessive force was applied during clip application.The localization of the treatment in the ascending colon indicates that the endoscope was held in a strongly angled position and that there was most likely high counter-pressure against the clip.This can lead to a more difficult clip application.Due to the angled position and the tissue counter-pressure, the clip was only advanced on one side.The slight forward movement of the white application ring was mistakenly considered successful clip application.It was also reported when the endoscope was retracted, the clip deployed from the cap.This also supports the assumption that clip application was prevented by the rigid tissue.The clip application must be verified by the user before tissue 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 2021.
Event or Problem Description
It was reported that the colonic ftrd was used for the treatment of a scarred lesion in the ascending colon.After turning the hand wheel the white application ring slightly advanced on one side.It was mistakenly assumed that the clip had been applied and the tissue was resected.The resulting perforation was closed with clips within the same procedure.The clip eventually deployed outsite the patient.The patient stayed in hospital overnight and recovered well.

• Brand Name: COLONIC FTRD SET
• Common Device Name: COLONIC FTRD SYSTEM 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: 22025504
• Report Number: 3006696607-2025-00009
• Device Sequence Number: 20610295
• Product Code: PKL
• UDI-Device Identifier: 04260206311010
• UDI-Public: 04260206311010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Foreign,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: 04/30/2023
• Device Model Number: 14
• Device Catalogue Number: 200.70
• Device Lot Number: 825497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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: Other
• Patient Sex: Unknown