Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.Reported event pressure sensor not detected.The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a symphion fluid management accessories kit was to be used in the uterus during a uterine resection procedure performed on (b)(6) 2016.According to the complainant, during preparation, the controller displayed an error that the pressure sensor of the fluid management accessories was not detected.The procedure was completed using another symphion fluid management accessories kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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