Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Note: trichomoniasis is a sexually transmitted disease, our investigation revealed that the patient had a previous report of previous trichomoniasis infections, there was no cervix manipulation from the physician.Trichomoniasis can cause pelvic inflammatory disease if left untreated.Https://www.Mayoclinic.Org/diseases-conditions/trichomoniasis/symptoms-causes/syc-20378609.
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It was reported by a physician on(b)(6) 2021, that a patient who received an acessa procedure on (b)(6) 2021 was seen a few months later and was experiencing a vaginal discharge, with a high white blood cells count and fever.The patient was diagnosed with trichomoniasis and pelvic inflammatory disease.The patient received antibiotic treatment and in the next follow up did not show any more symptoms.Her uterus had shrunk since the surgery and her symptoms had 100% improved.22 fibroids were observed during the surgery and 20 were treated.The physician reported that he did not use a uterine manipulator and therefore put nothing through the cervix to go into the uterus.No other information is available.
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