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

Model Number ML18080-K0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Patient with history of stage iv follicular lymphoma was admitted for an ultrasound biopsy of lymph node.While physician was doing the procedure, the medax srl unipersonale medeasy soft tissue semi-automatic biopsy needle came unglued.Another biopsy needle was used and it came unglued as well.Both biopsy needles had the same lot #.A third biopsy needle was used without problems.No known harm done to patient.This is the 6th report of this biopsy needle coming unglued.Purchasing department is aware and has all lot numbers: 21-121, 21-75, 21-67, 21-64.

• 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: 12016283
• MDR Text Key: 256715937
• Report Number: 12016283
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 08054301667419
• UDI-Public: (01)08054301667419(17)250401(11)200501(10)0618620
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ML18080-K0
• Device Lot Number: 0618620
• 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: 06/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 70