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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 MAM3008
Device Problem Mechanical Problem (1384)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/08/2020
Event Type  malfunction  
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.
 
Event Description
Devicor medical products, inc.Received a report by sales representative of a mam3008 tip shear during a procedure.Tip of deployment device cut off in patient.This has been documented in our system as record #(b)(4).
 
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Brand Name
MAMMOMARK
Type of Device
BIOPSY 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 MEXICO
sor juanaines de la cruz
#20152 4-b
parque industrial, 22440
MX   22440
Manufacturer Contact
jack cummings
300 e business way
fifth floor
cincinnati, OH 45241
MDR Report Key9679771
MDR Text Key197600264
Report Number3008492462-2020-00002
Device Sequence Number1
Product Code NEU
UDI-Device Identifier00841911101659
UDI-Public(01)00841911101659(17)201219(10)F11924449D
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/19/2020
Device Model NumberMAM3008
Device Catalogue NumberMAM3008
Device Lot NumberF11924449D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2020
Initial Date FDA Received02/06/2020
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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