MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BIOPSY POSITIONER

Model Number	FDR-2000BPY
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Perforation (2001); Skin Tears (2516)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Fujifilm was informed that during a biopsy exam a needle mispuncture occurred in germany.A biopsy on the patient was performed and the needle drove too deep into the patient's breast, passing through the calcification (z axis stroke too long).The (vacuum) needle penetrated the caudal skin of the patient.The needle was pulled back into the position of the calcification and the operator (physician) was able to extract a biopsy sample.The exam could be finalized and the patient was sent home after treating the cut with an adhesive bandage.There was no death or serious injury associated with this event; this incident is being reported in an abundance of caution.This event was reported to the manufacturer on (b)(6) 2019.The manufacturer reported this event to fda under report # 3001722928-2019-00009.

• Brand Name: FUJIFILM BIOPSY POSITIONER
• Common Device Name: BIOPSY POSITIONER
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 12445821
• Report Number: 1000513161-2021-00013
• Device Sequence Number: 3581973
• Product Code: IZH
• UDI-Device Identifier: 04547410336047
• UDI-Public: (01)04547410336047(11)170801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FDR-2000BPY
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1