MAUDE Adverse Event Report: Hologic, Inc. Sertera Biopsy Device; INSTRUMENT, BIOPSY

Model Number	Sertera-14
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that during a breast biopsy procedure on (b)(6)2026, "the radiologist was doing an u/s "[ultrasound]" guided core biopsy and stated that he took 3 samples and all three samples came back "shredded".He then switched needles and the new needle samples were good." no patient and/or user harm was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.Investigation is ongoing.

• Brand Name: Sertera Biopsy Device
• 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 dr; newark, DE 19702
• MDR Report Key: 50942525
• Report Number: 1222780-2026-00660
• Device Sequence Number: 13159082
• Product Code: KNW
• UDI-Device Identifier: 15420045504066
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150169
• 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): 09/30/2026

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: Sertera-14
• Device Catalogue Number: Sertera-14
• Device Lot Number: E26E26RL
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown