MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CORVOCET; INSTRUMENT, BIOPSY

Model Number	00884450316672
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly patient with history of left upper lobe nodule, having a ct for biopsy of left lung.Biopsy device was opened for biopsy and upon attempting to fire the device the needle would not fire.No harm was done to patient.

• Brand Name: CORVOCET
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 10277544
• Report Number: 10277544
• Device Sequence Number: 2697810
• Product Code: KNW
• UDI-Device Identifier: 00884450316672
• UDI-Public: (01)00884450316672(17)230225(10)H1784915(01)00884450316672
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/30/2020
• Report Date (Section F): 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450316672
• Device Catalogue Number: CORCA2015B/A
• Device Lot Number: H1784915
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 06/30/2020