MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BIOPSY POSITIONER

Model Number FDR-2000BPY

Device Problem Malposition of Device (2616)

Patient Problems Perforation (2001); Skin Tears (2516)

Event Date 06/19/2019

Event Type  Injury  

Event 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
• Type of Device: BIOPSY POSITIONER
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 12445821
• MDR Text Key: 270512064
• Report Number: 1000513161-2021-00013
• Device Sequence Number: 1
• Product Code: IZH
• UDI-Device Identifier: 04547410336047
• UDI-Public: (01)04547410336047(11)170801
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FDR-2000BPY
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1