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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 MAM308
Device Problem Device Damaged by Another Device (2915)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis, which precluded a full investigation and analysis of the root cause. However, based on information received from the customer the event occurred as a result of the user removing the marker applicator separately from the probe. Tip shear has been identified as a potential risk whenever the applicator shaft is removed separately through the biopsy probe once it has been positioned in the probe aperture for marker deployment. Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue. Removing the applicator shaft once it is exposed to the probe aperture creates the possibility of the applicator catching on one of these edges and shearing. As a mitigation step to address this risk, we provide warnings and precaution language and instruction within the instructions for use: warning: failure to align the mammomark applicator as specified may result in improper deployment of the collagen plug and possible tip shear. Warning #10: remove the mammomark applicator and the mammotme biopsy probe together as a single unit from the site and obtain images to confirm marker placement. A patient update is not available at this time. However, due to the potential for a subsequent procedure or other treatment intervention, pursuant to 21 cfr 803, we are submitting this medwatch report.
 
Event Description
The rsm reported that dr. Said she noticed a tip shear on a follow up patient yesterday. She inquired about what to do. Rep told her we could provide a letter that describes the material of hte tip. She is waiting for that and will communicate the issue to the patient in the coming days/weeks. Device was an hh8bex and marker was a mam3008. Device is not available for return.
 
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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 juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key6382766
MDR Text Key69202658
Report Number3008492462-2017-00010
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 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAM308
Device Catalogue NumberMAM3008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
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

Patient Treatment Data
Date Received: 03/06/2017 Patient Sequence Number: 1
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