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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 0913-20
Device Problems Bent (1059); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2017
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.Currently unable to establish a relationship or impact to the reported observation.Internal reference complaint#: (b)(4).
 
Event Description
It was reported a physician completed an eviva breast biopsy on (b)(6) 2017 and when the needle was removed from the patient's breast, "the tip of the probe was bent/twisted".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 Key7067351
MDR Text Key93743733
Report Number1222780-2017-00275
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/15/2019
Device Model Number0913-20
Device Catalogue NumberEVIVA 0913-20
Device Lot Number17F15RD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2017
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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