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

Model Number CORA1815

Device Problems Loose or Intermittent Connection (1371); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

The biopsy device's adjustment mechanism became loose and caused it to not fire properly.

• 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: 13440502
• MDR Text Key: 284980226
• Report Number: 13440502
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CORA1815
• Device Catalogue Number: CORA1815
• Device Lot Number: L2201366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2022
• Date Report to Manufacturer: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female