MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. INSTINCT; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	G18344
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Homeostasis clip would not close all the way.This was noted prior to inserting into patient.A new clip was obtained and was placed successfully.

• Brand Name: INSTINCT
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8050421
• Report Number: 8050421
• Device Sequence Number: 1787061
• Product Code: PKL
• UDI-Device Identifier: 00827002183445
• UDI-Public: (01)00827002183445(17)210710(10)W4088656
• 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): 11/02/2018
• Report Date (Section F): 11/02/2018

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: No Information
• Device Model Number: G18344
• Device Catalogue Number: INSC-7-230-20-S
• Device Lot Number: W4088656
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/02/2018