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

Catalog Number CORCA1815SB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

During biopsy the device detached after the second specimen was collected.

• Brand Name: CORVOCET
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 15103020
• MDR Text Key: 296592783
• Report Number: 15103020
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CORCA1815SB
• Device Lot Number: 12330694
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female