MAUDE Adverse Event Report: HOLOGIC, INC ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 7300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 04/08/2023

Event Type  Injury  

Event Description

It was reported that a patient was admitted on (b)(6) after received an acessa procedure and novasure ablation on (b)(6) 2023.The procedure was reported that the patient had 3 larger fibroids treated with acessa during the initial procedure each measuring around 7-8cm.One of the fibroids was described as fundal and the least one of them was near the endometrial cavity.The physician as well stated that the cavity measured 16 cm and that it was a large uterus.The novasure procedure lasted 30 seconds.The patient complained of pain and is having copious amounts of discharge of dark color.The patient was admitted to the hospital.The patient had been admitted 2 times to the emergency department previously, it is unknown the date of the first admission.The patient had an transvaginal ultrasound performed and showed a possible abscess at the fundus.The patient had showed high white blood cell count and possible uti symptoms as well.The physician reported that she did not provide any post procedure antibiotics and the patient is currently receiving a course of antibiotics after her first visit to the emergency room (doxycycline and flagyl).The patient was reported to be much clinically better and her white cell count went from 15000 to 8000 and the fever had disappeared and was being discharged.

Manufacturer Narrative

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.

• Brand Name: ACESSA PROVU HANDPIECE
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 16832007
• MDR Text Key: 314176978
• Report Number: 1222780-2023-00145
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7300
• Device Catalogue Number: 7300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization