INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX)

Description of Event or Problem

BALLOON RUPTURED. IT WAS REPORTED THAT WHEN USING THE E-KIT, THE BALLOON RUPTURED AT 48ML INSIDE THE PATIENT. THE 2ND OCCURRENCE HAPPENED ON (B)(6)- IT WAS REPORTED THAT THEY SLOWLY INFLATED THE E-KIT TO 50ML AND AS IT WAS GOING UP TO THE LAST 7ML, IT STARTED TO LEAK.

Additional Manufacturer Narrative

AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 07/01/2006 TO 07/01/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION (B)(4). THERE IS ONE EVENT ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE FAT.