MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BIOPSY POSITIONER

Model Number FDR-2000BPY

Device Problem Malposition of Device (2616)

Patient Problems Perforation (2001); Tissue Damage (2104); Skin Tears (2516)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

Fujifilm believes that there could have been an interconnection problem between the biopsy positioner (device to guide the needle and place it in the correct position) and the aws (visualization & processing computer).This communication interruption may have been caused by a fuzzy connection or a loose connector between the biopsy unit and the amulet innovality main body (connector jack is mounted on the main body).Fujifilm (b)(4) dispatched an engineer to the customer site on (b)(6) 2019.The engineer was not able to find any loose connections.The engineer was not able to reproduce the problem during multiple tests.The system's log data was provided to fujifilm (b)(4) experts and a root cause analysis is in progress.In the case of automatic puncturing, an error message is displayed when there is a possibility that the tip of the puncturing needle comes in contact with the surface of the x-ray detector, and the puncturing operation is not performed automatically.In a situation where a puncturing operation is performed manually, a warning sound is generated when the distance between the tip of the puncture needle and the surface of the x-ray detector becomes less than 6 mm.Fujifilm believes that needle penetration cannot normally occur.If any additional relevant information becomes available, a supplemental report will be submitted.

Event Description

Fujifilm was informed that during a biopsy exam a needle mispuncture occurred in (b)(6).Procedure 1, patient 1: pre-shots, used for calculating the location of the microcalc and biopsy positioner / needle position, were performed without problems.After the exposures the biopsy positioner (the biopsy add-on device holding and positioning the needle) generated an error message "process communication not possible" followed by error message "error while saving target info".Patient 1 was sent home, and no biopsy was performed.The operator rebooted the unit and no error was visible.The operator performed daily accuracy check after the reboot without errors or other problems.Procedure 2, patient 2: a biopsy on patient 2 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 associated with this event; this incident is being reported in an abundance of caution.

Event Description

Fujifilm was informed that during a biopsy exam a needle mispuncture occurred in germany.Procedure 1, patient 1: pre-shots, used for calculating the location of the microcalc and biopsy positioner / needle position, were performed without problems.After the exposures the biopsy positioner (the biopsy add-on device holding and positioning the needle) generated an error message "process communication not possible" followed by error message "error while saving target info." patient 1 was sent home, and no biopsy was performed.The operator rebooted the unit and no error was visible.The operator performed daily accuracy check after the reboot without errors or other problems.Procedure 2, patient 2: a biopsy on patient 2 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 (physicican) 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 associated with this event; this incident is being reported in an abundance of caution.

Manufacturer Narrative

Country code is not populating correctly; initial reporter country was entered in address line 2.Manufacturer narrative: fujifilm believes that there could have been an interconnection problem between the biopsy positioner (device to guide the needle and place it in the correct position) and the aws (visualization & processing computer).This communication interruption may have been caused by a fuzzy connection or a loose connector between the biopsy unit and the amulet innovality main body (connector jack is mounted on the main body).Fujifilm germany dispatched an engineer to the customer site on 26 jun 2019.The engineer was not able to find any loose connections.The engineer was not able to reproduce the problem during multiple tests.The system's log data was provided to fujifilm japan experts and a root cause analysis is in progress.In the case of automatic puncturing, an error message is displayed when there is a possibility that the tip of the puncturing needle comes in contact with the surface of the x-ray detector, and the puncturing operation is not performed automatically.In a situation where a puncturing operation is performed manually, a warning sound is generated when the distance between the tip of the puncture needle and the surface of the x-ray detector becomes less than 6 mm.Fujifilm believes that needle penetration cannot normally occur.If any additional relevant information becomes available, a supplemental report will be submitted.On 30 sep 2019 fujifilm corporation was notified of additional information.It was found that the (optional) biopsy spacer was used in an upside flipped position at the time of the questionable examination.The biopsy spacer is used to position the breast firm under the compression paddle.The biopsy spacer is normally used to ensure the thickness of the breasts during compression.Using the spacer in "flipped position" is not the intended use of this accessory.Intended use and cautions are described in the operation manual.The local radiographers confirmed that they sometimes deliberately perform examinations with the biopsy spacer in "flipped position" to have better access to the lower breast segments and to be able to perform biopsy exams at a deeper part of the patient's breast.The operating doctor could not recall if he used the spacer or not at this examination, but photo evidence showed that the spacer was used, and the biopsy needle would not penetrate the caudal skin of the patient unless the spacer is used in "flipped position".Fujifilm corporation concluded that the root cause of the incident was identified as misoperation of the system.Countermeasures to avoid future misoperation have been communicated and put into place at the customer site to avoid similar incidents in the future.If any additional relevant information becomes available, a supplemental report will be submitted.

• Brand Name: FUJIFILM BIOPSY POSITIONER
• Type of Device: BIOPSY POSITIONER
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 8808829
• MDR Text Key: 209400289
• Report Number: 3001722928-2019-00009
• Device Sequence Number: 1
• Product Code: IZH
• UDI-Device Identifier: 04547410336047
• UDI-Public: (01)04547410336047(11)170801
• Combination Product (y/n): N
• PMA/PMN Number: K191495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FDR-2000BPY
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1