JAWZ EMB FORCEPS
Received Sep 1, 2017 · Event occurred Aug 3, 2017
Report 1625425-2017-00121 · MDR key 6840486
Device
Generic name
Endomyocardial Biopsy Forceps
Manufacturer
Argon Medical Devices Inc.Catalog number
190081
Lot number
G38301
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
- No Information
Narrative
Additional 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.
Description of Event or Problem
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.