MAUDE Adverse Event Report: COOK INCORPORATED INSTINCT; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	G18344
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Clip deployed inside scope prior to use.Physician noted that while he was advancing clip catheter down the biopsy channel he met some resistance and when the catheter came through the tip of the scope that the clip was detached.

• Brand Name: INSTINCT
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 8873328
• Report Number: 8873328
• Device Sequence Number: 16674037
• Product Code: PKL
• UDI-Device Identifier: 00827002183445
• UDI-Public: (01)00827002183445(17)220502(10)W4210807
• 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): 07/16/2019
• Report Date (Section F): 07/18/2019

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: G18344
• Device Catalogue Number: INSC-7-230-20-S
• Device Lot Number: W4210807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78
• Date Report Sent to FDA: 07/18/2019