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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK BIOPSY SITE MARKERS BREAST BIOPSY MARKER

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HOLOGIC, INC. TRIMARK BIOPSY SITE MARKERS BREAST BIOPSY MARKER Back to Search Results
Model Number TRIMARK-EVIVA
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2017
Event Type  Injury  
Manufacturer Narrative
We received 4 boxes qty
=
10 per box of eviva trimark-2s-13 new factory sealed biopsy site markers. The investigator along with an r+d representative randomly selected 3 new unused markers, all lot # 604583 from each of the 4 boxes of returned product. All 12 markers deployed a single marker only as designed. Complaint was not verified in product investigation lab. This observation will be monitored and trended. (b)(4).
 
Manufacturer Narrative
The device is not being 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 Description
It was reported the physician performed an eviva needle breast biopsy on (b)(6) 2017, and the single release system deployed two markers causing a potential risk for misdiagnosis. There was no patient injury.
 
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Brand NameTRIMARK BIOPSY SITE MARKERS
Type of DeviceBREAST BIOPSY MARKER
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
sidra piracha
250 campus drive
marlborough, MA 01752
5082638884
MDR Report Key6980827
MDR Text Key109933003
Report Number1222780-2017-00262
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K023450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/08/2018
Device Model NumberTRIMARK-EVIVA
Device Lot Number604583
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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