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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SECURMARK MRI; BIOPSY SITE MARKER
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HOLOGIC, INC. SECURMARK MRI; BIOPSY SITE MARKER Back to Search Results
Model Number SMARK-M-SS2
Device Problem Failure to Eject (4010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2018
Event Type  malfunction  
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.Internal complaint reference: (b)(4).
 
Event Description
It was reported that "during mri biopsy of breast, clip did not deploy properly at end of procedure.Patient had to have another procedure with ultrasound guidance to place the clip." no injury or misdiagnosis reported.
 
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Brand Name
SECURMARK MRI
Type of Device
BIOPSY SITE 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 Key8121738
MDR Text Key129035642
Report Number1222780-2018-00240
Device Sequence Number1
Product Code NEU
UDI-Device Identifier15420045503984
UDI-Public15420045503984
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/27/2018
Device Model NumberSMARK-M-SS2
Device Catalogue NumberSMARK-M-SS2
Device Lot Number17L27R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2017
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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