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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
Medical Device Problem Code Erratic or Intermittent Display (1182)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As of today the investigation is still in process and a follow up will be filed as needed.
 
Event or Problem 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.
 
Event or Problem Description
It was determined that the bcm needed to be replaced.Once this was completed the system was working as intended.
 
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Brand Name
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Common Device Name
BIOPSY GUIDANCE SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key8560945
Report Number1220984-2019-00042
Device Sequence Number2192000
Product Code IZH
UDI-Device Identifier15420045505858
UDI-Public15420045505858
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K122836
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/03/2019
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 NumberSTLC-00004
Device Catalogue NumberSTLC-00004
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/03/2019
Supplement Date Received by Manufacturer05/10/2019
Initial Report FDA Received Date04/29/2019
Supplement Report FDA Received Date05/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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