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

Model Number	ATEC SAPPHIRE
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during a breast biopsy the device experienced a negative pressure failure.The customer also reported that when the cutting command was triggered by the foot pedal, the inner cutter did not operate.As a result, the specimen chamber could not retain the sample, leaving the specimen chamber empty.To successfully obtain a pathological specimen, the procedure was converted from minimally invasive vacuum-assisted biopsy to open excision surgery.The surgical incision was enlarged to complete the lesion sampling.Upon follow up, no further harm was confirmed.No further information 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
• 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: 50006228
• Report Number: 1222780-2026-00451
• Device Sequence Number: 18750603
• Product Code: KNW
• UDI-Device Identifier: 15420045504295
• UDI-Public: 15420045504295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE
• Device Catalogue Number: ATEC SAPPHIRE
• 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: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• 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: Other
• Patient Sex: Unknown