ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG
Received Aug 13, 2018 · Event occurred Jul 1, 2018
Report 3032391-2018-00008 · MDR key 7776814
Device
Generic name
Ethicon Endopath® Xcel¿ Blunt Tip Trocar, W/smooth Sleeve & Adjustable Plug
Manufacturer
Medline RenewalCatalog number
H12LPRH
Lot number
377933
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A REPROCESSED ETHICON H12LP FELL APART DURING A LAPAROSCOPIC CHOLECYSTECTOMY. PER REPORT, THE SURGEON WAS ABLE TO LOCATE AND SUCCESSFULLY RETRIEVE ALL THE BROKEN PIECES FROM THE PATIENT THROUGH AN UNKNOWN METHOD. THE REPORTING FACILITY STATED THAT THEY WERE ABLE TO GRAB ANOTHER DEVICE AND THE SURGERY COMMENCED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF SERIOUS INJURY, ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THE INCIDENT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, RENEWAL IS FILING THIS MEDWATCH REPORT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A REPROCESSED ETHICON H12LP FELL APART INTO PATIENT DURING LAPAROSCOPIC CHOLECYSTECTOMY.