NEEDLE ELECTRODE
Received Mar 10, 2015 · Event occurred Feb 2, 2015
Report 1717344-2015-00182 · MDR key 4585416
Device
Generic name
Es Accessory
Manufacturer
Covidien LpModel number
E1552Catalog number
E1552
Lot number
40410134X
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE NEEDLE TIP OF THE DEVICE WAS MISSING WHEN THE DEVICE WAS HANDED FROM THE SURGEON TO THE SURGICAL TECH. THE TIP WAS LOCATED. ANOTHER NEEDLE TIP WAS OPENED AND USED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
(B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4). THE INCIDENT SAMPLE WERE NOT RETURNED TO COVIDIEN FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THREE DEVICES WAS PROVIDED. REVIEW OF THE PHOTOGRAPH FOUND THAT THE TIP OF TWO NEEDLE ELECTRODES WERE MELTED INTO A BALL AND CHARRED AS IF EXPOSED TO EXCESSIVE HEAT. NOTHING WAS MISSING OR BROKEN FROM THE DEVICES. NO DAMAGE WAS NOTED ON THE THIRD ELECTRODE IN THE PICTURE. THE E1552 INSTRUCTIONS FOR USE STATE NEEDLE ELECTRODES ARE DESIGNED FOR PRECISE LOW POWER USE DURING MONOPOLAR ELECTROSURGERY. USING A NEEDLE AT HIGH POWER FOR EXTENDED PERIODS OF TIME MAY RESULT IN DAMGE TO THE NEEDLE. ALWAYS USE THE LOWEST POWER SETTING THAT ACHIEVES THE DESIRED SURGICAL EFFECT.