ORS-100 FLUID WARMER DRAPE

Additional Manufacturer Narrative

A SAMPLE WAS RECEIVED FOR EVALUATION. THREE BURN MARKS/HOLES WERE OBSERVED ON THE DRAPE. THE FIRST BURN MARK/HOLE WAS ABOUT 1/2 INCH FROM THE CENTER OF THE DRAPE, THE SECOND BURN MARK/HOLE WAS ABOUT 1 1/2 INCHES AWAY FROM THE CENTER OF THE DRAPE AND THE THIRD WAS ABOUT 2 INCHES FROM THE CENTER OF THE DRAPE. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) CASES THAT WERE MANUFACTURED FROM 02/20/2017 TO 02/21/2017. NO DEFECTS RELATED TO THE NON CONFORMANCE WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THE MALFUNCTION DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, 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. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

A MEDWATCH FORM WAS RECEIVED ON 1/12/2018 WITH THE FOLLOWING INFORMATION: "IRRIGATION WARMER DRAPE HAD A HOLE THAT ALLOWED THE IRRIGATION TO COME IN CONTACT WITH UNSTERILE SURFACE. THIS WAS BROUGHT TO SURGEON'S ATTENTION DURING A CHIARI DECOMPRESSION SURGERY." NO ADVERSE EVENT WAS REPORTED FOR THE INCIDENT.