HOLOGIC, INC ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESORIES)
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Model Number 7300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Event Description
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It was reported on (b)(6) 2023, that an acessa procedure was performed 3 months ago, and the patient came back with severe pain and a white blood cell count of 30,000.The patient was hospitalized for a month, and had a diagnostic laparoscopy.When pain didn¿t resolve te patient had an open myomectomy.The doctor said fibroids were completely necrotic (white and black) and ¿scooped them out¿.Pathology on the fibroids showed mycoplasma.Patient is doing better after fibroids were removed, still has pain but it is much better.No additional 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.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.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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