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U.S. Department of Health and Human Services

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

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HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Back to Search Results
Model Number STLC-00004
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
As of today the investigation is still in process and a follow up will be filed as needed.
 
Event Description
It was reported that "the bcm monitor is flickering and will change views and sometimes the targets. " no injury reported. A field engineer was dispatched to the site.
 
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Brand NameAFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Type of DeviceBIOPSY GUIDANCE 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 Key8560945
MDR Text Key143423526
Report Number1220984-2019-00042
Device Sequence Number1
Product Code IZH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTLC-00004
Device Catalogue NumberSTLC-00004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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