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

Model Number	ML18080-K0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An upper-middle aged female with history of coronary artery disease, factor v leyden mutation, and hypertension, presented to emergency dept with abdominal pain.Having an ultrasound biopsy of abdominal core.After inserting into the patient, the biopsy needle was not firmly attached to the plastic base.Device removed and a replacement was used.No known harm to the patient.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: 11574113
• Report Number: 11574113
• Device Sequence Number: 3621887
• 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: Health Professional
• Device Model Number: ML18080-K0
• Device Lot Number: 06186-20
• Was Device Available for Evaluation?: No
• 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: 104
• Date Report Sent to FDA: 03/24/2021