MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG FTRD SYSTEM SET

Model Number	200.70
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since there was only a picture of the device provided and the device itself was disposed by the user facility, the root cause analysis is based on assumptions.Based on the complaint pattern/experience gained in europe, hardware-related causes why the clip does not deploy are basically absent.In virtually, all cases of such non-deployments were user-related.Potential error sources are mistakes in set-up (e.G.Pinching the thread) or use (entangling the grasper in the thread).However, the user has to ensure the clip application by visually controlling the white application ring.The instructions for use do clearly point this out.
Event or Problem Description
Within the endoscopic treatment of a flat poly at the transverse colon, a ftrd system set was used.The user did not deploy the clip and started resectioning with the hf-snare (clip and snare are both integrated parts of the ftrd system), resulting in a colon perforation.The patient went immediately to surgery for a laparotomy where the perforation was closed.The patient is doing fine.

• Brand Name: FTRD SYSTEM SET
• Common Device Name: FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; dorfackerstrasse 26; tuebingen, 72074 ; GM 72074
• MDR Report Key: 7600290
• Report Number: 3006696607-2018-00001
• Device Sequence Number: 210047
• Product Code: FDI
• UDI-Device Identifier: 04260206310556
• UDI-Public: (01)04260206310556(17)200731(10)805075
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: 200.70
• Device Catalogue Number: 200.70
• Device Lot Number: 805075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention