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

Model Number	ATEC SAPPHIRE 200
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, an eviva procedure was going to be performed, and when the needle was assembled on the atec sapphire, the unit failed the setup test.It was troubleshot due to the canister not being completely closed to allow for the vacuum.The atec sapphire was retested and passed all tests.The eviva was inserted into the breast for biopsy, and the atec sapphire failed to collect the sample and error coded ("vacuum ready" solid red).The needle was removed from the breast and retesting was attempted but failed.The procedure was aborted and the patient rescheduled for a new procedure.No additional information available.
Additional Manufacturer Narrative
Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.H3: the field engineer reseated the signal cable.Rearranged cables and air tubes.Cleaned vacuum valve inside.The device is working as per manufacture specifications.If additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

• Brand Name: ATEC SAPPHIRE
• Common Device Name: BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 16832499
• Report Number: 1222780-2023-00147
• Device Sequence Number: 1929843
• Product Code: KNW
• UDI-Device Identifier: 15420045504110
• UDI-Public: (01)15420045504110(11)211129
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE 200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female