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 09/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.
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Event Description
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It was reported that a patient underwent a myomectomy procedure, using a myosure disposable device, on (b)(6) 2022.However; during the procedure, her uterus got perforated.As reported, no damages to adjacent organs were observed.No device malfunction or any alarm did occur that could be related to this adverse event.The surgeon conducted a laparoscopy to identify the perforation and closed it.The patient has been hospitalized and she is now doing well.No other information is available.
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Manufacturer Narrative
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Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.
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Event Description
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It was reported that a patient underwent a myomectomy procedure, using a myosure disposable device, on (b)(6) 2022.However; during the procedure, her uterus got perforated.As reported, no damages to adjacent organs were observed.No device malfunction or any alarm did occur that could be related to this adverse event.The surgeon conducted a laparoscopy to identify the perforation and closed it.The patient has been hospitalized and she is now doing well.No other information is available.
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Search Alerts/Recalls
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