WARMER DRAPE

Additional Manufacturer Narrative

SAMPLE RECEIVED ON 1/11/2016, MANUFACTURER REVIEWED IT ON 1/13/2016. SAMPLE DRAPE WAS SOAKED IN BLEACH WATER FOR ABOUT AN EXTENDED PERIOD OF TIME (1.5 HR +), RINSED, AND LET DRY. CHECKED SAMPLE AND TOOK PHOTOS OF BURN MARKS AND BURN HOLE. REVIEW OF THE SAMPLE DRAPE FOUND TWO 2 INCH BURN MARKS 2 INCHES FROM THE CENTER OF THE DRAPE AND A SMALL BURN HOLE 3 INCHES FROM THE CENTER OF THE DRAPE AND 5 INCHES DOWN. A LOT NUMBER WAS NOT PROVIDED AND THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BUT AFTER INSPECTION OF THE RETURN SAMPLE THE PRODUCT APPEARS TO BE MANUFACTURED TO SPECIFICATION. THIS NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. AFTER REVIEWING THE SAMPLE, IT IS CONCLUDED THAT THE HOLES APPEAR TO BE MELTS OR BURNS IN THE DRAPE. THE BURN MARKS AND BURN HOLE DO NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ERROR. MELTS CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

Description of Event or Problem

AFTER THE CASE WAS DONE, STAFF NOTICED THAT THERE WAS WATER ON THE BOTTOM OF THE SOLUTIONS WARMER. THE STAFF NOTED THAT THERE WAS A HOLE IN THE ACTUAL DRAPE. THE SURGEON WAS NOTIFIED AND THE PROCEDURE STANDARD OF CARE WAS CHANGED FROM "CLEAN CONTAMINATED" TO "CONTAMINATED."

Additional Manufacturer Narrative

SAMPLE RECEIVED ON 01/11/2016, MANUFACTURER REVIEWED IT ON 01/13/2016. SAMPLE DRAPE WAS SOAKED BLEACH WATER FOR ABOUT AN EXTENDED PERIOD OF TIME (1.5 HR. +), RINSED AND LET DRY. CHECKED SAMPLE AND TOOK PHOTOS OF BURN MARKS AND BURN HOLE. REVIEW OF THE SAMPLE DRAPE FOUND TWO 2 INCH BURN MARKS 2 INCHES FROM THE CENTER OF THE DRAPE AND A SMALL BURN HOLE 3 INCHES FROM THE CENTER OF THE DRAPE AND 5 INCHES DOWN. A LOT NUMBER WAS NOT PROVIDED AND THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BUT AFTER INSPECTION OF THE RETURN SAMPLE THE PRODUCT APPEARS TO BE MANUFACTURED TO SPECIFICATION. THIS NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. AFTER REVIEWING THE SAMPLE, IT IS CONCLUDED THAT THE HOLES APPEAR TO BE MELTS OR BURNS IN THE DRAPE. THE BURN MARKS AND BURN HOLE DO NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ERROR. MELTS CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

Description of Event or Problem

AFTER THE CASE WAS DONE, STAFF NOTICED THAT THERE WAS WATER ON THE BOTTOM OF THE SOLUTIONS WARMER. THE STAFF NOTED THAT THERE WAS A HOLE IN THE ACTUAL DRAPE. THE SURGEON WAS NOTIFIED AND THE PROCEDURE STANDARD OF CARE WAS CHANGED FROM "CLEAN CONTAMINATED" TO "CONTAMINATED."