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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM; BREAST BIOPSY NEEDLE
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HOLOGIC, INC. EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM; BREAST BIOPSY NEEDLE Back to Search Results
Model Number 1213-20
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Reference internal complaint: (b)(4).
 
Event or Problem Description
It was reported that during a biopsy exam the needle bent and a portion of the tip dislodged.No injury reported.No additional information was provided.
 
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Brand Name
EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM
Common Device Name
BREAST BIOPSY NEEDLE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key7797222
Report Number1222780-2018-00191
Device Sequence Number18889116
Product Code KNW
UDI-Device Identifier25420045504995
UDI-Public25420045504995
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K042290
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) 07/23/2018
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 Date12/20/2019
Device Model Number1213-20
Device Catalogue NumberEVIVA_1213-20
Device Lot Number17M20RQ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2018
Initial Report FDA Received Date08/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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