The suspect medical device was not returned to the manufacturer for evaluation/investigation.Since no malfunction of an olympus medical device was reported, the suspect medical device is assumed to meet its specification.However, the exact cause of the patients' outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (serial number) are missing.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.
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Olympus was informed about the literature study ¿outcomes of surgical hysteroscopy: 25 years of observational study¿.The aim of this study was to analyse the complications arising from operative hysteroscopies performed during the last 25 years at hospital parc taulí de sabadell and to describe their differences according to the type of procedure performed.3.063 operative hysteroscopies were performed, 52.7% were polypectomies and 31.5% were myomectomies.Myectomies had the highest incidence of complications, at 14%, followed by septolysis, at 6.9%.The most common complications were mechanical (52%).Myomectomies had seven times higher risk than polypectomies of distension-medium complications but three times lower risk of mechanical complication.The highest incidence of complications occurred in type i myomas and those larger than 3 cm.If study defines fluid-balance complications as only those patients who absorbed more than 1.5 l and developed related symptoms, overall complication rate, including all mechanical complications, was 5.6%.The type of adverse events occurred during the study at hand are cervical tear, uterine perforation, false cervical route, vaginal tear, false endometrial route, hemorrhage, hyponatremia, electrical complications as well as anesthesia complications.The study indicates that the mechanical injuries of before mentioned adverse events were produced with different instruments, the hysteroscope itself (24%).11 patients required surgery to treat their complication.However, throughout the study report there was no report of a malfunction of any of the olympus medical devices.
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