HOLOGIC, INC. MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM
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Model Number 10-401FC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyanosis (1798); Perforation (2001); Tachycardia (2095)
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Event Date 09/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is 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.
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Event Description
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It was reported that during the procedure, the doctor dilated with metal dilators.The doctor resected intended pathology, took the device out, did scraping and then saw blood.The fluid deficit jumped to 2490ml.At that point it was realized the doctor had cut into the rectum.Anesthesia then noted the patient needed to be woken up immediately as she was tachycardic and lips were turning grey.Reportedly, the patient was sewn up.She was transported to the icu.No additional details available at this time.
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Search Alerts/Recalls
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