NEEDLE ELECTRODE
Received Mar 10, 2015 · Event occurred Feb 2, 2015
Report 1717344-2015-00184 · MDR key 4585325
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).INCIDENT SAMPLES WERE NOT RETURNED TO COVIDIEN FOR EVALUATION. REVIEW OF PHOTOGRAPHS PROVIDED BY THE CUSTOMER FOUND THAT TWO OF THREE NEEDLE TIPS WERE CHARRED AND MELTED AS IF EXPOSED TO EXCESSIVE HEAT. THE THIRD NEEDLE DID NOT DISPLAY ANY DAMAGE. NOTHING WAS IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORT THAT THE NEEDLE WAS MISSING OR FELL OUT OF THE PENCIL.
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.