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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 190051
Device Problems Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the package device history record and inspection records was conducted and no similar concerns were found. The returned device was evaluated and the issue was confirmed since the biopsy jaws do not open. This product is purchased fully packaged from a supplier. A supplier corrective action request has been sent to the supplier. A follow-up report will be submitted when the supplier provides their evaluation and conclusions.
 
Event Description
Patient admitted for cardiac biopsy to rule out amyloidosis. Upon attempt to retrieve tissue sample the endomyocardial biopsy forcep became stuck in the superior vena cava (svc) right atrial junction and failed to open or release despite multiple attempts to open up. Patient was subsequently admitted emergently to the operating room where a sternotomy and small venotomy was completed to remove the biopsy forcep.
 
Manufacturer Narrative
A review of the device batch record was performed for (b)(4), in-process and finished goods and there were no non-conformances or capas opened in relation to the nature of the complaint. All devices met all (b)(4), in-process and finished goods specifications upon release of the product. The returned device was evaluated by the supplier. Per the supplier, ¿the device was returned with the introducer still attached. The introducer was removed and the device was laid across the work bench. There were several severe bends in the outer jacket caused by over-actuation. The forceps would not open. The distal end of device was inspected under 10x magnification and it was clear that there was dried fluid preventing the jaws from opening. The jaws were soaked in hydrogen peroxide and the dried fluids were removed with a razor blade. Once a significant amount of dried fluid was removed, the jaws were able to open and close when actuated. These devices are functionally tested 100% prior to packaging. There is no root cause investigation at this time. Once the device was cleaned with hydrogen peroxide the jaws were able to open and close as intended even with the bends in the outer jacket. ¿.
 
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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 Key6573438
MDR Text Key75432111
Report Number1625425-2017-00072
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190051
Device Lot NumberG14888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2016
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: 05/17/2017 Patient Sequence Number: 1
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