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

Model Number	RM-ATEC PEARL
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	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user that prior to an atec pearl biopsy procedure on (b)(6) 2026, "tech tested the needle and everything was fine.When the doctor would do the biopsy by pressing the pedal, it would not work.Eventually, it worked but when the doctor took her foot off the pedal, it took two more samples." no patient harm was reported; however, injury mdr is being submitted due to unintended additional tissue being removed from the patient.
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 PEARL
• 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: 25350464
• Report Number: 1222780-2026-00342
• Device Sequence Number: 10302166
• Product Code: KNW
• UDI-Device Identifier: 15420045506855
• UDI-Public: 15420045506855
• 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): 06/01/2026

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 PEARL
• Device Catalogue Number: RM-ATEC PEARL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/01/2026
• 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