ENDOPATH ENDOSCOPIC INSTRUMENT, CURVED SCISSORS W/MONOPOLAR CAUTERY

Description of Event or Problem

IT WAS REPORTED THAT, THE INSULATION AT THE TIP OF THE DEVICE IS GETTING STUCK IN THE 5 MM PORTS AND STARTING TO TEAR WHEN THEY USE THE DEVICE. A NEW DEVICE WAS OPENED TO REPLACE BAD PRODUCT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE INSULATION AT THE TIP OF THE DEVICE IS GETTING STUCK IN THE 5 MM PORTS AND STARTING TO TEAR WHEN THEY USE THE DEVICE. A NEW DEVICE WAS OPENED TO REPLACE BAD PRODUCT. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.