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

Model Number	00884450476406
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by staff, "biopsy device appeared to fire but only blood was on the needle instead of a 20 mm tissue specimen." associate reporting indicated two devices failed both with the same lot number (being reported) requiring a third device to be opened and used to complete the procedure (device lot number that was successfully used is unknown).

• Brand Name: CORVOCET
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w. merit parkway; south jordan UT 84095
• MDR Report Key: 12083492
• Report Number: 12083492
• Device Sequence Number: 11593966
• Product Code: KNW
• UDI-Device Identifier: 00884450476406
• UDI-Public: (01)00884450476406
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/21/2021
• Report Date (Section F): 06/21/2021

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: 00884450476406
• Device Catalogue Number: CORCA1815SB/B
• Device Lot Number: 12075811
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2021
• 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: 06/21/2021