MAUDE Adverse Event Report: MERMAID MEDICAL A/S M-BIOPSY®; SEMI AUTOMATIC BIOPSY INSTRUMENT 20GX12CM

Model Number	N30120012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The m-biopsy semi-automatic gun has self released when loading for the third biopsy.Further information and the used product is about to be collected from the customer.

• Brand Name: M-BIOPSY®
• Common Device Name: SEMI AUTOMATIC BIOPSY INSTRUMENT 20GX12CM
• Manufacturer (Section D): MERMAID MEDICAL A/S; frydensbergvej 25; stenløse, DK-36 60; DA DK-3660
• MDR Report Key: 9249797
• Report Number: 3007146453-2019-00001
• Device Sequence Number: 3462244
• Product Code: KNW
• UDI-Device Identifier: 15711055002346
• UDI-Public: 15711055002346
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K161409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/10/2019

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 Expiration Date: 08/08/2024
• Device Model Number: N30120012
• Device Catalogue Number: N30120012
• Device Lot Number: P001378
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1