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(b)(6) was a (b)(6) y/o female who was admitted to the (b)(6) hosp for elective hysteroscope, dilation and curettage of uterine fibroid by gynecologist dr (b)(6) on (b)(6) 2018.There was an uneventful induction with midazolam oxycodone and sevoflurane.The cervix was dilated and reaction commenced.There was nil active bleeding in the cavity as per operation report.There was abrupt desaturation and fall in etco2 with associated pallor, cyanosis (contemptuous with resection of the fibroid).(b)(6) became bradycardic with a loss of output.Cpr was commenced and there was return of circulation after approx 10 mins.(b)(6) was intubated and transferred to the (b)(6) icu.(b)(6) was subsequently transferred to the (b)(6) hosp icu where she had w ecmo with two further pea arrests with further cpr post transfer from the (b)(6) hosp icu.She went into biventricular heart failure and sustained acute kidney injury with overload, positive blood cultures, multiple hemodynamic supports.She had superior vena cava and jv thrombus on ultrasound and was found to have severe hypoxic brain injury and end of life care was commenced.(b)(6) died on the (b)(6) 2018.The (b)(6) coroners office case file (b)(6) stated the cause of the death was air embolism complicating dilation and curettage of uterine fibroid.The (b)(6) hosp through a professor (b)(6), chief medical officer, executive dir academic and med services, (b)(6) wrote to (b)(6) with concerns regarding the hysteromat easi med device (mfg by the karl storz company based in (b)(4) and approved for use by the (b)(6) and the fda) used during (b)(6) operation.(b)(6) was advised of safety concerns about the hysteromat easi and the actions of the (b)(6) to remove the hysteromat from their facilities.The (b)(6) has indicated that they intend to advise health services of the potential safety of the device and to encourage reporting of any known issues.This would include, but not limited to, if healthcare facilities have experienced any issue relating to variability in fluid pressure and / or fluid delivery from the device.The (b)(6) are also aware of the issue concerning the new updated model of the hysteromat easi and at this stage (b)(6) is not planning a formal recall, so will not be directing health services to cease the use of the hysteromat easi medical device.The (b)(6) were sent a video that demonstrated the hysteromat easi appearing to malfunction and at present the (b)(6) are conducting their own investigation into the device.I am contacting the fda directly as i believe that the hysteromat easi medical device is defective and poses a threat to women who undergo surgical procedure where this device is used.I also wish to state that another female person also underwent the same surgical procedure as (b)(6) about 6 weeks after (b)(6) and suffered a life threatening air embolism at the (b)(6) hosp.At this stage, it was becoming evident to all concerned that the hysteromat easi medical device was the common denominator for both procedures.I believe the (b)(6) with the benefit of a video supplied by the bioengineering dept of the (b)(6) hosp is not acting fast enough to prevent further adverse events including death where this device is used in surgical procedures.Please remember that in the usa where this machine is in use some medical facilities may not realize that the hysteromat easi device has malfunctioned during a procedure and where there has been an adverse event put it down to the fact that air embolism is a rare adverse risk of having a hysteroscopic procedure.I do hope the fda can read my submission and hopefully save some lives.Regards, (b)(6).Fda safety report id# (b)(4).
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