MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE CONSOLE; INSTRUMENT, BIOPSY

Model Number	ATEC SAPPHIRE
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) during an atec sapphire procedure was performed, and the device lost suction during the biopsy procedure, and the physician is unable to confirm if calcifications were retrieved, and may need to repeat the procedure.No additional information is available.

• Brand Name: ATEC SAPPHIRE CONSOLE
• 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: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15697165
• Report Number: 1222780-2022-00346
• Device Sequence Number: 7384394
• Product Code: KNW
• UDI-Device Identifier: 15420045504295
• UDI-Public: 15420045504295
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• 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
• Report Date (Section B): 10/29/2022

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
• Device Model Number: ATEC SAPPHIRE
• Device Catalogue Number: ATEC SAPPHIRE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female