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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM
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HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM Back to Search Results
Model Number PBX-SYS-AFFIRM-3D
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/18/2019
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 "needle hit array and now causing artifact." additional information obtained noted that during a breast biopsy when the needle fired an odd sound was heard and the patient had some discomfort.The patient was numbed more and the biopsy was completed successfully.No medical intervention was needed.A field engineer was dispatched to the site.
 
Event or Problem Description
It was determined that the needle stroke margin needed to be corrected.Once this was completed by an applications specialist the system was working as intended.
 
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Brand Name
AFFIRM PRONE BIOPSY SYSTEM, 3D
Common Device Name
BREAST BIOPSY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key8590336
Report Number1220984-2019-00049
Device Sequence Number2281386
Product Code IZH
UDI-Device Identifier15420045506510
UDI-Public15420045506510
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K153486
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) 04/18/2019
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 NumberPBX-SYS-AFFIRM-3D
Device Catalogue NumberPBX-SYS-AFFIRM-3D
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/18/2019
Supplement Date Received by Manufacturer04/18/2019
Initial Report FDA Received Date05/08/2019
Supplement Report FDA Received Date06/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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