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	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male patient.20x15cm corvocet needle biopsy system was opened and tested prior to use and the gun would not fire (not used on patient).A second needle was opened and tested and upon attempting to use it, the needle was not firing correctly and would not release the small core sample that was taken.No harm was done to the patient.After investigation, both products had the same lot#.There was a 3rd report done a few days later for the same product.It also had the same lot number.

• 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: 10275537
• Report Number: 10275537
• Device Sequence Number: 2603991
• Product Code: KNW
• UDI-Device Identifier: 00884450316672
• UDI-Public: (01)00884450316672(17)230225(10)H1784915
• 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): 07/01/2020
• Report Date (Section F): 07/01/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• 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
• 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: 07/01/2020