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. EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT
  • 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. EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT Back to Search Results
Model Number EVIVA_1213-20
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
 
Event or Problem Description
It was reported that during a biopsy procedure, following lavage the probe was rotated to help collapse the cavity and the patient complained of pain.The needle was seen to be bent on subsequent images.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM
Common Device Name
BIOPSY INSTRUMENT
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key11289758
Report Number1222780-2021-00027
Device Sequence Number3440311
Product Code KNW
UDI-Device Identifier15420045505889
UDI-Public15420045505889
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K180233
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/05/2021
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 Expiration Date07/29/2021
Device Model NumberEVIVA_1213-20
Device Catalogue NumberEVIVA_1213-20
Device Lot Number19G30RP
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/13/2021
Initial Report FDA Received Date02/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-