MAUDE Adverse Event Report: HOLOGIC, INC. MULTICARE PLATINUM; STEREOTACTIC BREAST BIOPSY SYSTEM

Model Number 8-004-0017

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Our field engineers were unable to duplicate as this was an intermittent issue.Replaced the stage pcb and recalibrated the stage as a precaution.

Event Description

The coordinates for targetting for a biopsy were off for this one patient.They had to send the patient to another clinic for the procedure.

• Brand Name: MULTICARE PLATINUM
• Type of Device: STEREOTACTIC BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: debra rosenberg ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2032074512
• MDR Report Key: 5699450
• MDR Text Key: 47651660
• Report Number: 1220894-2016-00013
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KO30666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: 8-004-0017
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1