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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 Imprecision (1307)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/26/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a superficial lesion was targeted and when the needle fired, it struck the detector.The biopsy was successfully completed and no additional intervention was required.A field engineer was dispatched to the site and it was determined that after a software upgrade the needle parameters were not enabled.The technologist selected an eviva 9g x13cm petite thinking it was the same as eviga 9gx13cm standard 20mm, which was not availabe/visible because it was not yet enabled.The correct needle type was enabled in the application.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 Key8601140
Report Number1220984-2019-00050
Device Sequence Number14023625
Product Code IZH
UDI-Device Identifier15420045505858
UDI-Public15420045505858
Combination Product (Y/N)N
Initial Reporter StateCA
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
Report Date (Section B) 04/26/2019
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? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2019
Initial Report FDA Received Date05/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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