COVIDIEN
Received Mar 11, 2019 · Event occurred Feb 12, 2019
Report 3032391-2019-00001 · MDR key 8409882
Device
Generic name
Ligasure Impact, Sealer/divider Nano-coated, Compatible With Ft10 Generator 18cm
Manufacturer
Medline RenewalCatalog number
LF4418C
Lot number
390958
Product problems
- Entrapment of Device
Patient
77 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A THIN METAL SPRING WAS FOUND INSIDE THE PATIENT DURING A LIVER RETRACTION PROCEDURE. THE REPORTING FACILITY WAS UNSURE IF THE SPRING CAME FROM THE REPROCESSED DEVICE (LIGASURE IMPACT, SEALER/DIVIDER NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 18CM) OR IF THE SPRING WAS LEFT IN THE PATIENT FROM A PROCEDURE YEARS PRIOR. THE SPRING WAS REPORTEDLY SUCCESSFULLY RETRIEVED FROM THE PATIENT THROUGH AN UNIDENTIFIED METHOD. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE DEVICE WAS RETURNED FOR EVALUATION AND THIS DEVICE HAD BEEN REPROCESSED BY MEDLINE RENEWAL. THE DEVICE WAS INSPECTED AND NO DAMAGE WAS FOUND. LF4418C DEVICES DO NOT HAVE SMALL SPRINGS MATCHING THE ONE FOUND IN THE PATIENT. THE SOURCE OF THE SPRING COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A THIN METAL SPRING WAS FOUND INSIDE THE PATIENT DURING A LIVER RETRACTION PROCEDURE.