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
Abscess (1690)
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Event Date 07/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that a patient received an acessa procedure on (b)(6) 2022, later the physician reported on (b)(6) 2022 that the patient had been admitted to the hospital for 2 weeks due to a severe infection.The patient has a pelvic abscess in the cul-de-sac behind the uterus.The physician expressed that he does not believe this would be the results of the acessa procedure since they only removed an anterior fibroid and did not treat the area, he said it could be related to a contamination of some sort.The patient is doing well and eating well.
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Search Alerts/Recalls
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