MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Model Number	STL-00004
Medical Device Problem Codes	Imprecision (1307); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, during an affirm upright biopsy system during a normal procedure , the samples could not retrieve the calcifications with the coordinates programmed in the machine.The procedure was ended prematurely and the patient had to be rescheduled for a new procedure.A field engineer examined the console and determined that the calibration had been done correctly and also revealed some internal communication errors.A mechanical system calibration was performed which revealed some motor axis errors found.The biopsy control module and biopsy guidance module were replaced and the system met the manufacturers specifications.No other information is available.

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
• Common Device Name: BIOPSY GUIDANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15695628
• Report Number: 1220984-2022-00088
• Device Sequence Number: 7367821
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (Y/N): N
• PMA/510(K) Number: K122836
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: STL-00004
• Device Catalogue Number: STL-00004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2013
• 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
• Patient Sex: Unknown