MAUDE Adverse Event Report: HOLOGIC, INC. MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY DEVICE; SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number	8-004-0017
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2015
Type of Reportable Event	Malfunction
Event or Problem Description
Wile performing daily qc on the stereotactic unit, the tech discovered that the needle test was out of limits and the compression paddle lock was broken.Due to this event the patient/exam double stereo scheduled for today was not able to be done and a single score biopsy had to be completed in the ultrasound dept.Patient will possibly have to return on another day to have the stereotactic biopsy done.

• Brand Name: MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY DEVICE
• Common Device Name: SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8105467
• Report Number: 8105467
• Device Sequence Number: 16661551
• Product Code: IZH
• UDI-Device Identifier: 15420045505926
• UDI-Public: (01)15420045505926
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/19/2018
• Report Date (Section F): 11/19/2018

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: 8-004-0017
• Device Catalogue Number: 8-004-0017
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/19/2018