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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 Consequences Or Impact To Patient (2199)
Date of Event 06/05/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a biopsy exam the radiologist bumped the stage arm and the arm moved causing the needle to move within the breast.No injury reported and the exam was able to be finished.A field engineer was dispatched to the site and determined that the lock ring in the stage compression assembly 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 & 37 apple ridge road
danbury CT 06810
MDR Report Key8732543
Report Number1220984-2019-00070
Device Sequence Number11406090
Product Code IZH
UDI-Device Identifier15420045506510
UDI-Public15420045506510
Combination Product (Y/N)N
Initial Reporter StateCT
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
Report Date (Section B) 06/05/2019
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? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/05/2019
Initial Report FDA Received Date06/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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