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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 MAM3001
Device Problem Mechanical Problem (1384)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
The mammomark biopsy site identifier is a sterile, single use device 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. However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking. The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker. Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast. Medical intervention is required to remove the sheared tip.
 
Event Description
It was reported by the sales rep that during an u/s guided biopsy using legacy biopsy device, ultrasound 11g, mam3001, had marker tip into patient breast during site marker deployment. Marker tip in patient's breast confirmed via post marker x-ray image. This event is documented in our system as complaint#(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 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 Key11325900
MDR Text Key248026059
Report Number3008492462-2021-00002
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAM3001
Device Catalogue NumberMAM3001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
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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