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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-0004
Device Problem Unintended System Motion (1430)
Patient Problem Not Applicable (3189)
Event Date 06/11/2018
Event Type  malfunction  
Event Description
It was reported that during a biopsy procedure, after firing the needle into the breast, the needle appeared to move in an upward motion and then in an anterior motion towards the nipple.No injury reported, however, the patient returned to complete the biopsy and it was reported that seven images were obtained which resulted in the patient receiving additional radiation.The system logs were evaluated by technical support and a field engineer was dispatched to the site.It was determined that the bcm control module needed to be replaced.Follow-up with the customer also noted that the technologist did not change the needle selection from petite to the standard needle that was being used for this procedure.
 
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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 Key7687453
MDR Text Key114036428
Report Number1220984-2018-00115
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
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSTLC-0004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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