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

Model Number	ATEC SAPPHIRE 100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a breast biopsy procedure on (b)(6) 2026, using an atec sapphire 100 system, the user reported "during clinical operations today the doctor notice that the samples size are smaller then usual." it was further reported that a patient "had to be clipped twice using a different needle for examination completion." injury mdr is being submitted due to the additional surgical intervention.A hologic clinical account manager (cam) visited the customer site on (b)(6) 2026, and ran tests on the atec system in conjunction with a customer site technician.The cam found the atec system to be working as intended.The cam further reported that the user site technicians "usually don¿t perform the first step of the atec ¿set up¿ and i instructed them to do so going forward.I also think that making sure the radiologist continuously keeps their foot on the foot pedal to keep the vacuum¿s momentum building will help with the tissue core sizes as well.".
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.

• 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: 25409968
• Report Number: 1222780-2026-00353
• Device Sequence Number: 13449516
• Product Code: KNW
• UDI-Device Identifier: 15420045504028
• UDI-Public: 15420045504028
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 06/05/2026

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: ATEC SAPPHIRE 100
• Device Catalogue Number: ATEC SAPPHIRE 100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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