MAUDE Adverse Event Report: HOLOGIC, INC CELERO-12; INSTRUMENT, BIOPSY

Model Number	CELERO-12
Medical Device Problem Codes	Failure to Obtain Sample (2533); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user that during a celero procedure on (b)(6) 2025, tissue samples were difficult to acquire, and the needle bent when it penetrated "hard tissue." it is reported that the needle was withdrawn from the patient's breast and the procedure was completed with another device; however, an x-ray was obtained to ensure no metal fragments remained inside the patient.It is reported that no foreign material was observed inside of the patient and the patient experienced no adverse health effects.No further information is currently available.
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.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the user that during a celero procedure on (b)(6) 2025, tissue samples were difficult to acquire, and the needle bent when it penetrated "hard tissue." it is reported that the needle was withdrawn from the patient's breast and the procedure was completed with another device; however, an x-ray was obtained to ensure no metal fragments remained inside the patient.It is reported that no foreign material was observed inside of the patient and the patient experienced no adverse health effects.No further information is currently available.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted, and signs of physical damage were found; the device had the inner cannula bent and the outer cannula was broken.Visual inspection revealed an inner and outer cannula damaged, consistent with the initial evaluation.Based on findings, the complaint was confirmed.Since this unit was visually verified, functionality testing was not required.The complaint was confirmed, and root cause analysis determined that the failure was attributable to the damage found in the inner and outer cannula, as identified during the internal inspection.Control points are in place at the production line to increase the detectability of the failure mode.Conclusion: the reported issue has been confirmed, and the most probable root cause has been identified.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: yes.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.

• 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: 23350244
• Report Number: 1222780-2025-00547
• Device Sequence Number: 12714731
• Product Code: KNW
• UDI-Device Identifier: 15420045504929
• UDI-Public: (01)15420045504929(17)270110(10)E25A10RA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: E25A10RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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