WARMER DRAPE

Additional Manufacturer Narrative

LOT D152501A, THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/08/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. 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

THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. THE WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM (B)(6).

Additional Manufacturer Narrative

FOLLOW UP #1. NOTE, WHEN THIS COMPLAINT WAS FIRST SUBMITTED, IT CONTAINED DUPLICATE INFORMATION AS FOUND IN THE MDR 8043817-2016-00014. THIS FOLLOW UP REPORT PROVIDES THE CORRECT INFORMATION ASSOCIATED WITH THIS COMPLAINT. THE LOT NUMBER PROVIDED REGARDING THIS COMPLAINT WAS NOT A VALID LOT NUMBER THEREFORE THE DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. ADDITIONALLY, NO SAMPLE WAS RETURNED. AS A VALID LOT NUMBER NOR RETURNED DEVICE WAS AVAILABLE FOR INVESTIGATION, THE NON CONFORMITY COULD NOT BE CONFIRMED AND NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. DEVICE NOT RETURNED.

Description of Event or Problem

AN END-USER CUSTOMER IS REPORTING DRAPES HAVE HOLES. THE DRAPE ARE LEAKING DURING SCOPE WARMING PROCEDURES.