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	Breast Discomfort/Pain (4504)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that during an atec pearl breast biopsy procedure on (b)(6) 2026, the "machine kept taking biopsies even after the radiologist took her foot off the foot pedal." it is further reported that the device had to be turned off to prevent more samples from being acquired.It is reported that the biomed at the user facility tested the device with a training needle and found that it would not finish the cycle of testing.Additionally, the user facility biomed reports that "i checked all the connections and then checked the airlines coming out of the machine to the foot pedal.I noticed that they were kinked and tightly wound to machine." it is reported that after correcting the lines, "the machine could cycle and was able to be stopped every time i lifted my foot off." it is reported that the patient complained of pain.Injury mdr is being submitted due to the report of 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: 24954164
• Report Number: 1222780-2026-00176
• Device Sequence Number: 5264736
• Product Code: KNW
• UDI-Device Identifier: 15420045506855
• UDI-Public: 15420045506855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 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: 03/31/2026
• 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