MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG OTSC SYSTEM SET; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	11/6 A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Ovesco clamp would not deploy; tried twice; equipment malfunction.

• Brand Name: OTSC SYSTEM SET
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; 120 ovesco quade drive; cary NC 27513
• MDR Report Key: 9693311
• Report Number: 9693311
• Device Sequence Number: 11368345
• Product Code: PKL
• UDI-Device Identifier: 04260206310075
• UDI-Public: (01)04260206310075(17)220831(10)819558
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020
• Report Date (Section F): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11/6 A
• Device Catalogue Number: 100.09
• Device Lot Number: 819558
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88
• Date Report Sent to FDA: 01/27/2020