ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG
Received Jun 28, 2018 · Event occurred Jun 4, 2018
Report 3032391-2018-00006 · MDR key 7646389
Device
Generic name
Ethicon Endopath® Xcel¿ Blunt Tip Trocar, W/smooth Sleeve & Adjustable Plug
Manufacturer
Medline RenewalModel number
K012644Catalog number
H12LP
Lot number
378574
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- No Known Impact Or Consequence To Patient
- Foreign Body In Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE REPROCESSED ETHICON H12LP TROCAR BROKE INSIDE A PATIENT DURING A PROCEDURE. PER REPORT, THE PHYSICIAN WAS ABLE TO LOCATE THE BROKEN PIECE AND SUCCESSFULLY RETRIEVE IT FROM THE PATIENT. THE REPORTING FACILITY STATED THAT THEY WERE ABLE TO GRAB ANOTHER DEVICE AND THE SURGERY COMMENCED WITHOUT 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 THE REPROCESSED ETHICON H12LP TROCAR BROKE INSIDE A PATIENT.