MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TRU-CUT; INSTRUMENT, BIOPSY

Model Number	10884450443047
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of abdominal pain and cholelithiasis.Surgical procedure was robotically assisted cholecystectomy with liver biopsy and robotically assisted hernia repair with mesh.The tru-cut biopsy needle would not cut.Another product used, no known harm to patient.

• Brand Name: TRU-CUT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 11222426
• Report Number: 11222426
• Device Sequence Number: 14587007
• Product Code: KNW
• UDI-Device Identifier: 00884450443040
• UDI-Public: (01)00884450443040(17)230830(10)1873944
• 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): 01/14/2021
• Report Date (Section F): 01/14/2021

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: 10884450443047
• Device Catalogue Number: 2N2704X/B
• Device Lot Number: 1873944
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2021
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 01/14/2021