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

Model Number	00884450476390
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Corvocet biopsy gun came apart when the biopsy gun was fired.No known harm to patient.2nd incident in 2 days with same product, same lot number.Refer to medsun report (b)(4) manufacturer response for instrument, biopsy, corvocet¿ (per site reporter) will obtain.

• 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: 14619004
• Report Number: 14619004
• Device Sequence Number: 5140057
• Product Code: KNW
• UDI-Device Identifier: 00884450476390
• UDI-Public: (01)00884450476390(17)250110(10)12343163
• 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): 05/23/2022
• Report Date (Section F): 05/23/2022

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: 00884450476390
• Device Catalogue Number: CORCA1815B/B
• Device Lot Number: 12343163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2022
• 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: Unknown
• Date Report Sent to FDA: 05/23/2022