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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. MAMMOMARK BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS INC. MAMMOMARK BIOPSY SITE IDENTIFIER Back to Search Results
Model Number MRM4008
Device Problem Device Damaged by Another Device (2915)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/07/2018
Event Type  Injury  
Manufacturer Narrative
The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site. The device is not available for analysis, which precludes a full investigation and analysis of the root cause. Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue. Removing the marker delivery system separately from the probe aperture once the spring is exposed creates the possibility of it catching on one of these edges. As a mitigation step to address this risk, we provide instructions within the instructions for use: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement. Based on the patient consequence of an unintended piece of the device in the biopsy site, and the additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.
 
Event Description
Devicor medical products, inc. Received a report from sales stating, during the procedure the marker tip sheared off into the patient's breast. This has been documented in our system as record (b)(4).
 
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Brand NameMAMMOMARK
Type of DeviceBIOPSY SITE IDENTIFIER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS INC.
300 e. business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEDICAL
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california
Manufacturer Contact
jill burnett
300 e. business way
fifth floor
cincinnati, OH 45241
5138649047
MDR Report Key8175553
MDR Text Key130777029
Report Number3008492462-2018-00085
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMRM4008
Device Catalogue NumberMRM4008
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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