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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC EVIVA STEROTACTIC BREAST BIOPSY SYSTEM; BREAST BIOPSY NEEDLE
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HOLOGIC, INC EVIVA STEROTACTIC BREAST BIOPSY SYSTEM; BREAST BIOPSY NEEDLE Back to Search Results
Model Number 1213-20
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).
 
Event Description
It was reported a physician performed an eviva breast biopsy on (b)(6) 2017 and the " tip of the needle is bent after the biopsy".There was no patient injury.
 
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Brand Name
EVIVA STEROTACTIC BREAST BIOPSY SYSTEM
Type of Device
BREAST BIOPSY NEEDLE
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer Contact
sidra piracha
250 campus drive
marlborough, MA 01752
5082638884
MDR Report Key6714240
MDR Text Key80266713
Report Number1222780-2017-00183
Device Sequence Number1
Product Code KNW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042290
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/07/2018
Device Model Number1213-20
Device Catalogue NumberEVIVA 1213-20
Device Lot Number16K07RF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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