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

Model Number	ATEC SAPPHIRE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an atec sapphire procedure on (b)(6) the customer reported that they were experiencing intermittent issues with obtaining samples and that the samples were small and there was a different noise.It was confirmed that 2 patients required to be rescheduled for new procedures.The console was returned for investigation and it was found that the bulkhead connector was replaced and that the pressure switches and cutter strokes times needed calibration, the bulkhead connector was replaced, preventive maintenance was performed, console calibrated and tested and all testing passed.Console was refurbished.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• 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 ; CR 20102
• MDR Report Key: 22031583
• Report Number: 1222780-2025-00256
• Device Sequence Number: 12934629
• 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
• Report Date (Section B): 05/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE
• Device Catalogue Number: ATEC SAPPHIRE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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