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	05/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of esophageal cancer underwent a ct liver biopsy with a corvocet" 18 gauge 15cm needle (corvocet" soft-tissue biopsy procedure kit).The needle fired and engaged in use, but when it was retracted, there was no specimen.It was attempted several times with the same results.Needle was removed and another one used successfully.No known harm to patient.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: 11847651
• Report Number: 11847651
• Device Sequence Number: 3910437
• Product Code: KNW
• UDI-Device Identifier: 00884450476390
• UDI-Public: (01)00884450476390(17)231231(10)12061959
• 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): 05/10/2021
• Report Date (Section F): 05/10/2021

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: 00884450476390
• Device Catalogue Number: CORCA1815B/B
• Device Lot Number: 12061959
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 84
• Date Report Sent to FDA: 05/10/2021