MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE; INSTRUMENT, BIOPSY

Model Number	RM-ATEC SAPPHIRE
Medical Device Problem Codes	Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Dhr not available at the time of this report a follow up mdr will follow.
Event or Problem Description
It was reported that during an atec procedure on (b)(6) 2025, the foot pedal was not working correctly and could not produce a cut.Thus a patient had to be rescheduled for the 2nd half of a 2 site procedure.No other information available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported on (b)(6) 2025, that during a biopsy the foot pedal on the rm-atec sapphire system (b)(6) stopped triggering cut strokes to obtain samples.Air flow can be heard but the needle does not perform a cut stroke to obtain a biopsy sample.This occurred after the first biopsy of a 2-site procedure, and the patient had to be rescheduled for the second biopsy.Patient impact was reported since they had to be rescheduled and receive another incision in order to get the second biopsy.A replacement foot switch was sent to the customer for them to use.The atec system was shipped to the customer on may 2nd, 2024, and installed on (b)(6) 2024.There was a previous complaint for footswitch issues on (b)(6) 2024, and a replacement footswitch was sent.It is unclear when exactly the new footswitch was installed, but it was in use for a maximum of 27 days at the time of the complaint.Nothing was returned to hologic pmqa for investigation.Further investigation could not be performed as no parts were returned to pmqa or hologic¿s marlborough (ma) location for investigation.As no parts were returned for investigation, a definitive root cause is unable to be determined.Based on the details reported in the complaint, and similar complaints in the past, the most likely root cause is that there was an issue with the footswitch cable that prevented the signal to start the cut stroke from going to the system.This cannot be verified without the returned parts, however.Conclusion: based on the details reported in the complaints, the most likely root cause of the reported issue is that the footswitch was not sending signal to begin the cut stroke to the atec console, preventing the sample from being taken.It was reported that air flow could still be heard, so the footswitch was partially able to communicate with the console.Because the footswitch and atec system were not returned to hologic, a deeper investigation into the root cause could not be performed.A replacement footswitch was sent to the customer to resolve the issue.Device history record (dhr) review: system serial number: (b)(6) system sku: rm-atec sapphire system rm date: (b)(6) 2024 system installation date: (b)(6) 2024 udi: (b)(4).System dhr review was performed and the device history record for the serial number involved was reviewed and was found to have met all manufacturing requirements prior to shipment for distribution.This includes final inspection and packaging inspections.No deviations are mentioned within the dhr.

• Brand Name: ATEC SAPPHIRE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21384572
• Report Number: 1222780-2025-00073
• Device Sequence Number: 20947791
• Product Code: KNW
• UDI-Device Identifier: 15420045504295
• UDI-Public: (01)15420045504295
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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
• Device Model Number: RM-ATEC SAPPHIRE
• Device Catalogue Number: RM-ATEC SAPPHIRE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown