MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE 100; INSTRUMENT, BIOPSY

Model Number	RM-ATEC SAPPHIRE 100
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.A follow up report will follow with the information from the dhr.
Event or Problem Description
It was reported by the user site on (b)(6) 2025, that "our atec does not have adequate suction.Doctors are needing to take additional tissue samples during at least 4 recent procedures.No error lights on system, handpieces from different lots used.All procedures completed successfully, 2 took longer than expected, filter was imaged on different system and then additional cores were collected." it is reported that additional tissue samples were required for at least four patient procedures; therefore, this is being reported due to additional medical/surgical intervention.The user site was provided with a replacement device.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the user site on (b)(6)2025, that "our atec does not have adequate suction.Doctors are needing to take additional tissue samples during at least 4 recent procedures.No error lights on system, handpieces from different lots used.All procedures completed successfully, 2 took longer than expected, filter was imaged on different system, and then additional cores were collected." it is reported that additional tissue samples were required for at least four patient procedures; therefore, this is being reported due to additional medical/surgical intervention.The user site was provided with a replacement device.Initial evaluation: the atec system was not sent to hologic post market quality assurance (pmqa) for investigation.The system had been in use for approximately 13 months at the time of the complaint, based on the install date and the date of the complaint.Investigation methods and findings: the atec system was not returned to hologic¿s post market quality assurance (pmqa) team for investigation, but was instead sent to hologic¿s marlborough, ma location to be serviced by a hologic manufacturing technician as part of a system refurbishment process.Based on the report completed by the technician, the needle valve was closed, and the cutter stroke time was out of the calibration.Cause/root cause: no further investigation could be completed into this issue since the unit was not returned to the pmqa lab.Based on the report filed by a hologic service engineer when repairing the system, the most probable root cause that can be determined could be the issue with the needle valve being closed.Conclusion: a health risk assessment (hra) was not deemed necessary, as the need to obtain additional biopsy samples is a known and expected potential outcome associated with biopsy procedures.Future complaints will be monitored and trended for this issue.Complaint confirmed: no device history record (dhr) review: system serial number: (b)(6) system sku: (b)(4) system manufacture date: 12/06/2023 system installation date: (b)(6)2024 udi: (b)(4).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.

• Brand Name: ATEC SAPPHIRE 100
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23871326
• Report Number: 1222780-2025-00642
• Device Sequence Number: 20166193
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/21/2026

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: RM-ATEC SAPPHIRE 100
• Device Catalogue Number: RM-ATEC SAPPHIRE 100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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