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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. JAWZ EMB FORCEPS ENDOMYOCARDIAL BIOPSY FORCEPS

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ARGON MEDICAL DEVICES INC. JAWZ EMB FORCEPS ENDOMYOCARDIAL BIOPSY FORCEPS Back to Search Results
Catalog Number 190081
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the device history records and inspection records was conducted and no similar concerns were found. No samples or photos were returned, so the issue could not be confirmed. Since the sample is not available for return and there were no concerns noted in the manufacturing documentation, no further evaluation can be conducted at this time.
 
Event Description
The insulation right behind the tip came free when the user pulled back on the handle. Of course, this happen while in the heart. The user thinks the spring was caught on the tricuspid valve. It took about five minutes of manipulating and the user was finally able to free it without ripping the valve.
 
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Brand NameJAWZ EMB FORCEPS
Type of DeviceENDOMYOCARDIAL BIOPSY FORCEPS
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key6840486
MDR Text Key85371429
Report Number1625425-2017-00121
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 09/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190081
Device Lot NumberG38301
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 Received08/03/2017
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

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