VITAL VUE

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TIP OF THE CATHETER SUDDENLY SPARKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM.

Additional Manufacturer Narrative

POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE ALL CONNECTIONS TO HANDLE HAD SEPARATED FROM THE HANDLE (THIS INCLUDES: THE IRRIGATION). SIGNS OF ADHESIVE SHEARING WAS OBSERVED ON THE BULB AND WIRING FIXTURE. THE BULB WAS FOUND TO BE BROKEN. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE REPORTED CONDITION MAY BE CAUSE BY BROKEN BULB\DAMAGED LIGHT FIXTURE. BULB BREAKAGE OR DAMAGE TO THE LIGHT FIXTURE MAY BE CAUSED BY APPLYING EXCESSIVE FORCE OR MANIPULATED THE DEVICE BEYOND INDICATED USE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.