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 Problem
Uterine Perforation (2121)
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Event Date 09/24/2019 |
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 is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device 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 distention was "tough from the start." the procedure lasted 20 minutes and the final deficit was 400.The procedure went well and the doctor placed an iud inside the patient.After the procedure, the doctor told the hologic representative that on initial sounding, the cavity length was 8, but post procedure it was 10.The doctor expressed concern that they may have perforated the patient uterus.The patient was put on antibiotics and was scheduled to return to the clinic on september 26th for an ultrasound to determine if there are any issues.No additional details received.
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