MAUDE Adverse Event Report: CAREFUSION 2200, INC TRU-CUT; INSTRUMENT, BIOPSY

Model Number	2N2704X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A "tru-cut" was used on patient for a liver biopsy.Upon removal of instrument after attempting to get specimen, it was noticed that the handle wouldn't retract.The tru-cut was removed in one piece, no pieces left in patient.Another tru-cut was given to surgeon and used without incident.

• Brand Name: TRU-CUT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10307383
• Report Number: 10307383
• Device Sequence Number: 16346607
• Product Code: KNW
• UDI-Device Identifier: 10885403110627
• UDI-Public: (01)10885403110627
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 07/06/2020
• Report Date (Section F): 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2N2704X
• Device Catalogue Number: 2N2704X
• Device Lot Number: 0001276892
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 07/06/2020