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

Model Number G58010

Device Problems Mechanical Problem (1384); Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Hemoclip failed to deploy inside patient.A second hemoclip was used instead.

• Brand Name: INSTINCT
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13250684
• MDR Text Key: 283766516
• Report Number: 13250684
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)240504(10)W4467610
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4467610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female