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

Model Number ML18160-K0

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Event 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
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDAX SRL UNIPERSONALE; 2769 mc cracken lane; castle rock CO 80104
• MDR Report Key: 13653144
• MDR Text Key: 286491926
• Report Number: 13653144
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 08054301667433
• UDI-Public: (01)08054301667433(17)250401(11)200501(10)ML18160K0
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 111 KG