ETHICON ENDOPATH® XCEL¿ BLADELESS TROCAR, W/STABILITY SLEEVE, 100MM LENGTH 5.0MM
Received Apr 23, 2018 · Event occurred Mar 29, 2018
Report 3032391-2018-00003 · MDR key 7450333
Device
Generic name
Ethicon Endopath® Xcel¿ Bladeless Trocar, W/stability Sleeve, 100mm Length 5.0mm
Manufacturer
Medline RenewalCatalog number
B5LT
Lot number
369119
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE CLEAR PLASTIC TIP OF A REPROCESSED ETHICON B5LT 5MM TROCAR BROKE OFF AS THE SURGEON WAS PULLING THE TROCAR OUT OF THE CANNULA, WHICH WAS STILL IN THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO LOCATE THE DETACHED TIP AND RETRIEVED IT FROM THE PATIENT WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THE INCIDENT. THE SAMPLE WAS RETURNED FOR EVALUATION AND IT WAS CONFIRMED THAT THE DEVICE WAS REPROCESSED. THE COMPLAINT WAS CONFIRMED HOWEVER; A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE CLEAR PLASTIC TIP OF A REPROCESSED ETHICON B5LT 5MM TROCAR BROKE.