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

Model Number	ML18080-K0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Middle aged female with thyroid nodule.Performing a radio-logical ultrasound guided core biopsy.The biopsy needle working guide came apart.2 sets used with the same lot # and came apart in the same fashion.A third device was used without problems.No known harm to patient.Please make note that 2 devices that malfunctioned with the same lot number.There was another incident that did the same thing the week before, but the device was not saved.

• Brand Name: MEDEASY
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDAX SRL UNIPERSONALE; via r. piva 1/a; poggio rusco mantova, it 46025
• MDR Report Key: 11574114
• Report Number: 11574114
• Device Sequence Number: 3622493
• Product Code: KNW
• UDI-Device Identifier: 08054301667419
• UDI-Public: (01)08054301667419(17)250401(11)200501(10)06186-20
• 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): 03/24/2021
• Report Date (Section F): 03/24/2021

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: No Information
• Device Model Number: ML18080-K0
• Device Lot Number: 06186-20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2021
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 03/24/2021