HOLOGIC, INC ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
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Model Number 7300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Oversedation (1990)
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Event Date 09/20/2023 |
Event Type
Death
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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.D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are 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.H3: 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.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 an acessa procedure took place on (b)(6) 2023, no other procedure took place.The procedure was reported as went smoothly, the physician ablated a few fibroids and the patient remained stable.Patient was closed and sent to recovery.After the procedure the physician noticed that the patient´s iv access were not clotting and additional the trocar sites were not clotting either.The patient was admitted for observation at this point and did not improve the condition.The patient at this point was taken to the operating room to assess the uterus and look for a potential cause which was not found and kept for observation.The patient received various doses of fentanyl and eventually was given narcan.The patient deteriorated and became unstable, cardiac issues were reported and cardiac massage was performed to stabilize the patient.Sadly the patient passed away over night.The physician reported that the death was believed not to be related to the acessa procedure and that the patient had an underlying clotting issue which exacerbated by the stress of the procedure additionally to a negative reaction to the fentanyl.No other information is available.
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