MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Model Number	STLC-00004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) a patient was lying down in the decubitus position with the affirm stereo biopsy unit set up in the cc position.The patient was in compression when the technologist attempted to adjust the target guidance monitor.The tech tried to move the monitor slightly towards the radiologist when the c-clamp became detached, causing the corner of the monitor to strike the patient in the eyebrow making a laceration.The patient required stitches.No additional information available.
Additional Manufacturer Narrative
On (b)(6), 2024, a patient was lying down in the decubitus position with the affirm breast biopsy guidance system (abbgs) (serial number (b)(6) set up in the craniocaudal (cc) position.The patient was in compression when the technologist attempted to adjust the biopsy control module (bcm).The technologist tried to move the bcm slightly towards the radiologist when the attachment bracket became detached, causing the corner of the bcm monitor to strike the patient in the eyebrow making a laceration.The patient required stitches.The procedure was able to be completed with the same device.This part was not returned.The part was not returned by the customer, so the investigation will be limited.The user manual for the abbgs states ¿make sure that this adjustment holds the bracket in position.If the bracket moves, or you cannot get the bracket to lock fully into position, adjust with the clamp adjust knob.¿ the customer stated that attachment may not have been tightened.There have been no prior complaints of this behavior on this system and no complaints since this incident.The customer was able to continue using biopsy control module and abbgs.The probable cause is user error for not ensuring that the attachment bracket was securely attached.The root cause is unknown.In summary, this event was most likely caused by the user who did not tighten the clamp adjust knob according to the user manual.The customer was able to continue using the biopsy control module (bcm) to complete the procedure and there was no alleged product defect.A corrective and preventive action (capa) for this event is not needed because this occurred due to user error despite the documented instructions.Additionally, the calculated risk index is low, which is acceptable.Future events will be trended and monitored.Complaint confirmed: no device history record (dhr) review: udi: (b)(4).Sku: rm-stlc-00004 serial number: (b)(6).Date of manufacture: 8/5/2022.Date of installation: unknown ¿ this information is not available.Shipped on date: 8/22/2022 incident date: (b)(6) 2024.Date of part manufacture: unknown.Dhr review summary: since this is the original part, a dhr review was performed.There were no discrepancies related to the biopsy control module (bcm).

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
• Common Device Name: BIOPSY GUIDANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 19934116
• Report Number: 1220984-2024-00084
• Device Sequence Number: 14143269
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: (01)15420045505858(11)220805
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: STLC-00004
• Device Catalogue Number: STLC-00004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown