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	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was here for a breast biopsy.Radiologist had one successful pass.The device was pre-fired, placed into the patient's breast, and the device failed to capture the specimen.The device was removed from the patient and the radiologist tried to press the capture button, but it would not budge.Therefore, a second device was opened and we successfully preceded with the biopsy.Device info: celero breast biopsy device 12 gauge.Ref: celero-12, lot# e23e05rp, exp 5/4/25.(b)(4).

• Brand Name: CELERO-12
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 19990346
• Report Number: 19990346
• Device Sequence Number: 8460952
• 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): 07/18/2024
• Report Date (Section F): 07/18/2024

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 Treatment Facility
• Date Report to Manufacturer: 08/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Date Report Sent to FDA: 07/18/2024