MAUDE Adverse Event Report: HOLOGIC, INC. AFFIRM UPRIGHT HOLOGIC; SYSTEM, X-RAY, MAMMOGRAPHIC

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  No Answer Provided  

Event Description

Affirm upright hologic machine would not allow us to perform needle localization for patient scheduled for surgery at the surgi-center.Error on machine populating "stage not latched." reboot, shut down, hard shut down.Error continues to populate.Unable to perform needle localization, surgi-center closing for the day, patient agreed to reschedule.Hologic called, qc performed.Serial number (b)(4), ticket number for hologic (b)(4).Service was performed on unit (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: AFFIRM UPRIGHT HOLOGIC
• Type of Device: SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 11300984
• MDR Text Key: 231209913
• Report Number: MW5099285
• Device Sequence Number: 1
• Product Code: IZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR