HOLOGIC, INC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM
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Model Number UNKNOWN |
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 07/15/2019 |
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 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.Internal reference#: (b)(4).
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Event Description
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This report pertains to the second of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report # 1222780-2019-00187.It was reported that during a fibroid removal procedure, pre endometrial ablation, the fluid deficit began to rise.After the fibroid was removed, the physician proceeded to the ablation procedure.The device passed cavity integrity assessment and the ablation was carried out.Post ablation laparoscopy revealed a uterine perforation and minor bowel burns.No additional details available.
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