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
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2019
Event Type  malfunction  
Manufacturer Narrative
As of today, the investigation is still in process and a follow up will be filed as needed.
 
Event 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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AFFIRM PRONE BIOPSY SYSTEM, 3D
Type of Device
BREAST BIOPSY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key8590336
MDR Text Key145541559
Report Number1220984-2019-00049
Device Sequence Number1
Product Code IZH
UDI-Device Identifier15420045506510
UDI-Public15420045506510
Combination Product (y/n)N
PMA/PMN Number
K153486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPBX-SYS-AFFIRM-3D
Device Catalogue NumberPBX-SYS-AFFIRM-3D
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-