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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ENDOMYOCARDIAL BIOPSY FORCEP DEVICE, BIOPSY, ENDOMYOCARDIAL

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ARGON MEDICAL DEVICES, INC. ENDOMYOCARDIAL BIOPSY FORCEP DEVICE, BIOPSY, ENDOMYOCARDIAL Back to Search Results
Model Number 190030
Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Reportedly, on three separate occasions and three separate patients, while obtaining a biopsy from myocardial tissue and attempting to pull the biopsy forcep out of the body, the forceps would not close. Reportedly, in one of the patients the sheath had to be removed and replaced in order to remove the forceps safely. Reportedly, there was no harm to any of the patients.
 
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Brand NameENDOMYOCARDIAL BIOPSY FORCEP
Type of DeviceDEVICE, BIOPSY, ENDOMYOCARDIAL
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd.
athens TX 75751
MDR Report Key7369302
MDR Text Key103416736
Report Number7369302
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190030
Device Catalogue Number190030
Device Lot Number3974116
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2018
Event Location Hospital
Date Report to Manufacturer03/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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