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

Model Number	CELERO-12
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was here for a breast biopsy.Prior to starting the procedure, the radiologist checked the celero device by pumping the handle and pre-firing the device.The handle would pump, but the device would not prefire.The device did not go into the patient's breast.Another device was opened, checked, and the procedure started and was completed successfully with the second celero device.Device info: celero breast biopsy device.Ref: celero-12.Lot: e23e05rp.Exp: 5/4/2025.Bar code #: (b)(4).

• Brand Name: CELERO-12
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 20155516
• Report Number: 20155516
• Device Sequence Number: 18217921
• Product Code: KNW
• UDI-Device Identifier: 15420045504929
• UDI-Public: (01)15420045504929(17)250504(10)E23E05RP
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2024
• Report Date (Section F): 08/09/2024

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: E23E05RP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Date Report Sent to FDA: 08/09/2024