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	Hematoma (1884)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported by the user site that during a celero biopsy procedure on (b)(6) 2025, "specimen was obtained using the pre-fire method.However, the biopsy needle would not reopen to retrieve the specimen.The hand "priming" function had zero resistance and did not appear to be working properly, so the 1 and 2 buttons did not respond when pushed.The biopsy sequence was attempted at least 15 times, without success.The patient developed a hematoma after the second pass and the area was no longer visualized, so the procedure was aborted.The pathology results were discordant, requiring a second biopsy several weeks later." no further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the user site that during a celero biopsy procedure on (b)(6) 2025, "specimen was obtained using the pre-fire method.However, the biopsy needle would not reopen to retrieve the specimen.The hand "priming" function had zero resistance and did not appear to be working properly, so the 1 and 2 buttons did not respond when pushed.The biopsy sequence was attempted at least 15 times, without success.The patient developed a hematoma after the second pass and the area was no longer visualized, so the procedure was aborted.The pathology results were discordant, requiring a second biopsy several weeks later." the device was not available for return; visual and functional analysis/testing could not be conducted for the described event.The device was not returned for this complaint, and only limited patient-related information was provided.Therefore, a full investigation could not be conducted.Without the returned sample, it is not possible to confirm a definitive root cause of the issue.Root cause analysis did not identify a definitive root cause.The investigation included a comprehensive review of complaint data and risk assessments, but could not perform any testing procedures, because the device was not returned.Conclusion: the reported issue could not be confirmed because the device was not returned.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23817055
• Report Number: 1222780-2025-00637
• Device Sequence Number: 13286502
• Product Code: KNW
• UDI-Device Identifier: 15420045504929
• UDI-Public: (01)15420045504929(17)270509(10)E25E09RB
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/19/2026

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: E25E09RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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