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

Model Number	00884450476475
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of right lung nodule was admitted for a ct scan-guided biopsy of right lung.The needle of the corvocet biopsy system was checked prior to using the device.The needle did not fire as it should have.Needle was not used on patient.A new needle was used for the case.No known harm 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: 12770132
• Report Number: 12770132
• Device Sequence Number: 19914965
• Product Code: KNW
• UDI-Device Identifier: 00884450476475
• UDI-Public: (01)00884450476475(17)230330(10)11821093(01)00884450476475
• 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): 11/03/2021
• Report Date (Section F): 11/03/2021

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: 00884450476475
• Device Catalogue Number: CORCA2010B/B
• Device Lot Number: 11821093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 11/03/2021