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

Model Number 8-004-0017

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  malfunction  

Event Description

It was reported that the x-axis is out of tolerance and tissue was missed on two patients."both patients have to be treated again." no injury reported.A field engineer was dispatched to the site and determined the x-axis potentiometer needed to be replaced.Once this was completed the system was working as intended.

• 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: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8048202
• MDR Text Key: 126521740
• Report Number: 1220984-2018-00169
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K030666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8-004-0017
• Device Catalogue Number: 8-004-0017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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