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 06/16/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that a patient received an acessa procedure on (b)(6) 2023.On (b)(6) hologic was notified that the patient was admitted to the emergency room with peritonitis.Patient was described as having inflammation around the adnexa and extends to the sigmoid.Patient was admitted and is receiving antibiotics via iv.Exam shows the fibroid which is infected and a small amount of fluid around the ovaries with inflammation of the mesentery around the ovaries that extends to the cecum, and possible inflammatory reaction.Additional information was received from the physician she reported that the patient had received prophylactic antibiotics.The ct scan showed swelling and post ablation changes including infraction and swelling of the larger fibroid as well as some fluid and fat stranding near the fibroid and mesentery of the bowel and sigmoid colon.No thickening of the wall of sigmoid colon.Tmax was 99 and white blood cell count went from 16 000 to 13 000 after 24 hours of antibiotics.The patient was doing well.No other information is available.

• 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: 17332770
• MDR Text Key: 319318862
• Report Number: 1222780-2023-00240
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 15420045515246
• UDI-Public: 15420045515246
• 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: 07/17/2023

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: 06/26/2023
• Initial Date FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1