HOLOGIC, INC ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESORIES)
|
Back to Search Results |
|
Model Number 7300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Fistula (1862)
|
Event Date 03/09/2023 |
Event Type
Injury
|
Event Description
|
It was reported on (b)(6) , an acessa procedure was performed in an unknown place, and the physician tried to ablate a fibroid pressing up against the uterine cavity, but no thick muscle lining.The patient was admitted back into the hospital due to a fistula.Currently, the patient is still being treated and is unknown the patient status.No additional information available.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|