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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 02/22/2019
Event Type  malfunction  
Event Description
It was reported that during a breast biopsy procedure, the needle penetrated through the patient breast and contacted the detector cover, no warning was received.A steri-strip was applied to the breast and no medical intervention was needed.A field engineer was dispatched to the site and determined that guidance hardware, geometry, and stx recalibration was needed.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 Key8417192
MDR Text Key138791286
Report Number1220984-2019-00020
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 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
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
Date Manufacturer Received02/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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