MAUDE Adverse Event Report: Hologic, Inc. ATEC SAPPHIRE 100; INSTRUMENT, BIOPSY

Model Number	ATEC SAPPHIRE 100
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a breast biopsy on july 8, 2026 that "the suction stopped working" and "needle fired and specimen was attempted.No specimen retrieved or taken due to no suction".The procedure was aborted and the patient required an additional biopsy procedure.Customer outreach confirmed "no additional harm was done to the patient or user", "the patient didn't require any additional medical or surgical intervention." that day, but "the biopsy was rescheduled and done the following week with a different needle".No further information is available at this time.
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device as the reported serial number (b)(6) did not populate in the hologic system, and no lot information was reported.A follow-up report will be submitted in the event additional information is received.

• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50091413
• Report Number: 1222780-2026-00467
• Device Sequence Number: 18595980
• Product Code: KNW
• UDI-Device Identifier: 15420045504028
• UDI-Public: 15420045504028
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/30/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/30/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown