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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 Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/26/2019
Event Type  malfunction  
Event 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
Type of Device
BIOPSY 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 Key8601140
MDR Text Key145268095
Report Number1220984-2019-00050
Device Sequence Number1
Product Code IZH
UDI-Device Identifier15420045505858
UDI-Public15420045505858
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
Report Date 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
Device Operator Health Professional
Device Model NumberSTLC-00004
Device Catalogue NumberSTLC-00004
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2019
Initial Date FDA Received05/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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