EZ CLEAN ELECTRODE, NEEDLE, MODIFIED
Received Feb 14, 2018 · Event occurred Jan 5, 2018
Report 1721194-2018-00003 · MDR key 7270798
Device
Generic name
Ez Clean Electrode, Needle, Modified
Manufacturer
Megadyne Medical ProductsModel number
0013MCatalog number
0013M
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
WITHOUT THE LOT NUMBER WE ARE UNABLE TO IDENTIFY THE MANUFACTURER OR EXPIRATION DATE OF THE DEVICE. REPEATED REQUESTS TO THE USER FACILITY HAVE BEEN UNSUCCESSFUL IN GAINING ACCESS TO THE DEVICE OR OBTAIN ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION. WITHOUT THE LOT NUMBER WE ARE UNABLE TO PERFORM A DEVICE HISTORY RECORD. A REVIEW OF THE PRODUCT HISTORY REVEALS THIS DEVICE TO BE A RELIABLE COMPONENT OF ELECTROSURGERY AND THERE IS NO EVIDENCE TO SUGGEST A DEVICE DEFECT OR MALFUNCTION. ALL THOUGH WE HAVE NOT BEEN ABLE TO CONFIRM THE EVENT, THE REPORT OF A OR FIRE IS INHERENT RISK WHILE USING ELECTROSURGERY AND THE CAUSES CAN BE VARIOUS.
Description of Event or Problem
CAUTERY PENCIL IN USE DURING PROCEDURE, RESULTING IN OR FIRE AND PATIENT INJURY.