MAUDE Adverse Event Report: Hologic, Inc. CELERO-12; INSTRUMENT, BIOPSY

Model Number	CELERO-12
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that during a biopsy procedure utilizing the device, the user was "obtaining core samples from patient during biopsy procedure.On the third pass the device would not engage, unable to open and retrieve core sample.Attempted multiple times to engage device to no effect.Had to utilize another." as a result of the reported device malfunction, tissue could not be obtained with the initial device.The procedure was completed using another device.
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 be submitted in the event additional information is received.

• Brand Name: CELERO-12
• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50839231
• Report Number: 1222780-2026-00606
• Device Sequence Number: 18651862
• Product Code: KNW
• UDI-Device Identifier: 15420045504929
• UDI-Public: 15420045504929
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K034021
• 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): 09/21/2026

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: CELERO-12
• Device Catalogue Number: CELERO-12
• Device Lot Number: E26E26RK
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown