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

Model Number	RM-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	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an atec sapphire biopsy procedure on (b)(6) 2026, the user experienced "low suction" and reports that only "a few small cores" were retrieved.The user reports that no error lights were observed and troubleshooting was attempted by switching the handpiece and canister; however, the issue persisted.Additional information was obtained from the user site, in which it was reported that "the procedure was completed with the device, but due to the inadequate samples, the patient had to return for a second/repeat biopsy." no further information is currently available.
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
• 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: 24954787
• Report Number: 1222780-2026-00177
• Device Sequence Number: 14804183
• Product Code: KNW
• UDI-Device Identifier: 15420045504295
• UDI-Public: 15420045504295
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: RM-ATEC SAPPHIRE
• Device Catalogue Number: RM-ATEC SAPPHIRE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/22/2026
• 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