MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG FTRD SYSTEM SET

Model Number 200.70

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

As the device was not sent back for technical analysis, respectively that incomplete (only accessories) the device master records of that lot were reviewed.Dmrs showed not any deviation that would indicate a manufacturing error.Furthermore, the complaint statistic do neither show any accumulation nor a trend.So far, there has never been a technical defect for clip deployment failure.According to the provided information, the user has assumed, that the clip was applied as it was not visible anymore.But within the training, which is mandatory before device usage, as well as within the instructions for use, it is clearly and highlighted described and trained, that the white ring needs to be observed.Only when the white ring has moved fully forwards to the edge of the cap, the user can be sure that the clip has been applied.It is technically impossible, that the clip does not release when the white ring has fully moved forwards to the edge of the cap.

Event Description

Within the endoscopic intervention of a non-lifting lesion, located at the appendiceal orifice, a ftrd system for endoscopic full thickness resection (eftrd) was used in order to save the patient from surgery in the first place.It was described, that the tissue was incredibly stiff and fibrotic and therefore not easy to pull into the ftrd cap.Clip was then attempted for deployment.The white ring, which is used for clip deployment and by which correct clip deployment can be controlled by user, advanced down towards the end of the cap but was still visible.The clip disappeared from endoscopic view.All persons present (physician, technician and nurse) agreed that the clip appeared to be deployed.The snare was then closed and tissue resected.Upon removal of the scope, it was noticed that the clip was still hanging onto the edge of the cap.In the same moment they noticed the clip, the clip released.Assessment of the site showed a perforation and patient was transitioned to laparoscopic surgery.

• Brand Name: FTRD SYSTEM SET
• Type of Device: FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; dorfackerstrasse 26; tuebingen, 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: 8064005
• MDR Text Key: 126937871
• Report Number: 3006696607-2018-00003
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04260206310556
• UDI-Public: (01)04260206310556(17)200331(10)804494
• 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: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 200.70
• Device Catalogue Number: 200.70
• Device Lot Number: 804494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention