ELECTRODE EXTENSION - 11"
Received Jul 8, 2009 · Event occurred Jun 9, 2009
Report 1717344-2009-00316 · MDR key 1473338
Device
Generic name
Electrosurgical Accessory
Manufacturer
Covidien Lp (valleylab)Catalog number
E1504
Lot number
101946
Product problems
- Loose or Intermittent Connection
- Component Missing
Patient
UNK
- Tissue Damage
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING A SUPRACERVICAL HYSTERECTOMY A FORCE TRIVERSE PENCIL WAS USED LAPAROSCOPICALLY WITH AN 11" EXTENDER. AFTER THE LAST ACTIVATION, THE PENCIL WAS WITHDRAWN FROM THE TROCAR AND LAID ASIDE. SHORTLY AFTERWARDS IT WAS NOTICED THAT THE ELECTRODE INSERTED IN THE EXTENDER WAS MISSING. X-RAYS SHOWED IT WAS STILL INSIDE THE PT. THE PROCEDURE WAS EXTENDED 2 HRS IN ORDER TO MAKE A MINI LAPAROTOMY INCISION TO FIND AND REMOVE THE TIP. NO OTHER COMPLICATIONS WERE NOTED IN F/U ON THE PT CONDITION. THE SITE REPORTED THAT THEY HAD NOTICED THAT THE TIP HAD BEEN LOOSE BEFORE USE BUT HAD THEN BEEN ENGAGED FULLY.
Additional Manufacturer Narrative
(B)(4). THE SITE DISCARDED THE DEVICES ASSOCIATED WITH THE COMPLAINT. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.