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

Model Number 200.70

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Internal Organ Perforation (1987)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Technical analysis showed that there are no deviations from specifications of the suspected device.The clip, application cap, handwheel and thread, being the components involved into clip application were all perfectly fine.According to the provided information, the user has not made sure that the clip has been properly applied before resectioning was begun.Differing from the instructions for use, the user has not controlled the white ring, that allows visually control of the clip application as it moves forwards to the edge of the cap.The user though to feel a haptic feedback of clip deployment.

Event Description

Within the endoscopic treatment of pre-resected positive carcinoma margins at the proximal cecum/ distal ascending colon with a fold involved, a ftrd system was used.The clip deployment was engaged while holding continuous tissue traction, clip visualization was lost as the physician engaged and continued reel turning of the handwheel until feeling a clip deployment.The user relied on the haptic feedback of the handwheel and started resection without visual confirmation of the clip deployment.Upon visualization of the site, the user recognized that the clip was not deployed, but there was also no perforation visible.A ct check confirmed then the possibility of perforation and the patient was then taken to the operation room for defect closure.Within surgery it could be confirmed, that the carcinoma was successfully resected and the perforation was also successfully closed.

• Brand Name: COLONIC FTRD SET
• Type of Device: FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; dorfackerstrasse 26; tübingen, 72074 ; GM 72074
• Manufacturer (Section G): OVESCO ENDOSCOPY AG; dorfackerstrasse 26; tuebingen, 72074 ; GM 72074
• Manufacturer Contact: matthias leenen ; dorfackerstrasse 26; tuebingen, 72074 ; GM 72074
• MDR Report Key: 8041013
• MDR Text Key: 126217530
• Report Number: 3006696607-2018-00002
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04260206311010
• UDI-Public: (01)04260206311010(17)210131(10)809029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 200.70
• Device Catalogue Number: 200.70
• Device Lot Number: 809029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention