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

Model Number	CELERO-12
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiologist was performing a breast biopsy on the patient.He was able to obtain 2 adequate samples.After retrieving the 2nd sample from the device, the device handle would not close and set to retrieve additional samples.Another device was opened and the biopsy continued.

• Brand Name: CELERO-12
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 21960736
• Report Number: 21960736
• Device Sequence Number: 9197573
• Product Code: KNW
• UDI-Device Identifier: 15420045504929
• UDI-Public: (01)15420045504929(17)261128(10)E24L28RB
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025
• Report Date (Section F): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CELERO-12
• Device Catalogue Number: CELERO-12
• Device Lot Number: E24L28RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Date Report Sent to FDA: 04/24/2025