NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT #1222780-2014-00099. IT WAS REPORTED THAT A PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014. THE PHYSICIAN RECEIVED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE PHYSICIAN REMOVED THE DISPOSABLE DEVICE AND RECHECKED THE PATIENT'S MEASUREMENTS AND NOTICED THE HYSTEROSCOPE TRAVELING "FAR INTO THE CAVITY-NOTED". THE PHYSICIAN PERFORATED AND ABORTED THE PROCEDURE. THE PATIENT WAS ADMITTED INTO THE HOSPITAL OVERNIGHT FOR OBSERVATION. THE PHYSICIAN PRESCRIBED ANTIBIOTICS FOR SEVEN DAYS AND NORETHISTERONE (BRAND NAME UNKNOWN) TO ASSIST WITH THE PATIENT'S MENORRHAGIA. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. A HYSTEROSCOPY AND DILATION, (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.
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Patient 1
LOT NUMBER OF THE SURE-SOUND NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS UNKNOWN. THE SURE-SOUND IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN NOT BE COMPLETED. LOT NUMBER OF THE SURE-SOUND NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE SURE-SOUND AS A LOT NUMBER WAS NOT PROVIDED BY COMPLAINANT. REFERENCE INTERNAL COMPLAINT CC#: (B)(4).