IN COMPLIANCE WITH REGULATORY REQUIREMENTS SUCH AS THOSE IN EUROPE, INSIGHTEC INITIATED A POST MARKETING SURVEILLANCE QUESTIONNAIRE TO CAPTURE CUSTOMERS FEEDBACK. ONE OF OUR CUSTOMERS, DR. (B)(6), CITED IN THEIR FEEDBACK THAT ONE OF THIS PATIENTS REPORTED A BOWEL PERFORATION. THEY ALSO ADDED THAT THEIR PATIENT SUFFERED WITH CHRONIC INFLAMMATORY DISEASE OF THE BOWEL. PATIENT WAS TREATED FOR THEIR UTERINE FIBROIDS WITH THE EXABLATE DEVICE. FOR LEGAL REASON, WE COULD NOT GET ANY ADDITIONAL DATA FROM THE SITE. HOWEVER, WE HAVE REVIEWED LAST YEAR SERVICE CALLS, DEVICE MAINTENANCE FILES AND ACTIONS AND FOUND NO ISSUES THAT COULD SUGGEST DEVICE HAS NOT BEEN WORKING ACCORDING TO ITS ORIGINAL SPECIFICATIONS AND OR THAT DEVICE EXPERIENCED DETERIORATION. HENCE, AT THIS TIME, WE ARE UNABLE TO MAKE A FULL REVIEW OF THE EVENT.
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FOR LEGAL REASONS, THE CUSTOMER WAS NOT ABLE TO PROVIDE ADDITIONAL DETAIL, WHEN REQUESTED BY INSIGHTEC. DUE TO THE LACK OF ADDITIONAL INFORMATION FROM THE CUSTOMER, INSIGHTEC CANNOT CONCLUDE WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THIS INJURY. IN AN ABUNDANCE OF CAUTION, THE COMPANY IS SUBMITTING THIS MDR REPORT BASED SOLELY ON THE INITIAL LIMITED INFORMATION PROVIDED TO THE COMPANY. IT SHOULD BE NOTED THAT THE REVIEW OF THE DEVICE HISTORY DID NOT SHOW ANY MALFUNCTION NOR DEVIATION FROM THE DEVICE NORMAL OPERATING SPECIFICATIONS.