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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 Unintended System Motion (1430)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/25/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a biopsy, after the customer took the first images, when the arm went to swing to do the second image the entire stage moved with it.The needle was in the patient breast, but no injury was reported.A field engineer was dispatched to the site.It was determined that the stage arm motor needed to be replaced, and the pin, and detent needed to be cleaned.Once this was completed, 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 apple ridge rd
danbury CT 06810
MDR Report Key10573104
Report Number1220984-2020-00072
Device Sequence Number3507993
Product Code IZH
UDI-Device Identifier15420045506510
UDI-Public(01)15420045506510
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K153486
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/25/2020
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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2020
Initial Report FDA Received Date09/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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