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 Date 10/05/2023 |
Event Type
Injury
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Event Description
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It was reported that on october 5th, an acessa procedure was performed and the patient came back to the hospital after the procedure with pelvic pain.Through testing, it was determined that the patient had a uti, and a piece of a broken humi uterine manipulator was found in the cervix and was removed.Also, a ct scan was performed and showed necrotic fibroids from where the patient was treated with acessa.The patient was given antibiotics and had 5 days of hospitalization.The patient is doing great.No additional information available.
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Manufacturer Narrative
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Di: (b)(4).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 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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Search Alerts/Recalls
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