MAUDE Adverse Event Report: MEDAX SRL UNIPERSONALE MEDEASY; INSTRUMENT, BIOPSY

Model Number	ML18160-K0
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Adult female with history of liver mass.Procedure: us guided biopsy of liver lesion.When packaging was opened for procedure, trochar removed and it was broken, it came off the hub.Device not used on patient - no known harm.Minor delay in procedure as new medeasy used.

• Brand Name: MEDEASY
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDAX SRL UNIPERSONALE; 2769 mc cracken lane; castle rock CO 80104
• MDR Report Key: 13653144
• Report Number: 13653144
• Device Sequence Number: 5826689
• Product Code: KNW
• UDI-Device Identifier: 08054301667433
• UDI-Public: (01)08054301667433(17)250401(11)200501(10)ML18160K0
• 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): 02/18/2022
• Report Date (Section F): 02/18/2022

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: ML18160-K0
• Device Lot Number: 06188-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 111 KG
• Date Report Sent to FDA: 02/18/2022