MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT HIGH TEMPERATURE CAUTERY PENS MALFUNCTIONED DURING SURGERY; THE PRODUCT WOULD NOT WORK CONSISTENTLY; WHEN CAUTERY DEVICE WAS ACTIVATED IT WOULD ONLY WORK INTERMITTENTLY. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

Description of Event or Problem

IT WAS REPORTED THAT HIGH TEMPERATURE CAUTERY PENS MALFUNCTIONED DURING SURGERY.