Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 03/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As of today the investigation is still in-process.A follow-up will be filed as needed.
 
Event or Problem Description
It was reported that during qas calibration the technologist was able to move the c-arm freely.No injury reported.A field engineer was dispatched to the site.
 
Event or Problem Description
The field engineer verified correct qas calibration multiple times.Documents were provided to the customer on the proper way to power off the table so the c-arm brake operates normally on power-up.The issue has not reoccurred as of today.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8491932
Report Number1220984-2019-00033
Device Sequence Number13847140
Product Code IZH
UDI-Device Identifier15420045506510
UDI-Public15420045506510
Combination Product (Y/N)N
Initial Reporter StateOH
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) 03/19/2019
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 03/19/2019
Supplement Date Received by Manufacturer04/04/2019
Initial Report FDA Received Date04/08/2019
Supplement Report FDA Received Date04/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-