MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA UTERINE FIBROID ABLATION DEVICE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

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

Patient Problem Rupture (2208)

Event Date 05/28/2019

Event Type  Injury  

Event Description

A (b)(6) y/o female underwent an acessa radiofrequency thermal ablation and hysteroscopic resection for treatment of her uterine fibroids on (b)(6) 2017.On (b)(6) 2019, she suffered a uterine rupture at 36 weeks 6 days gestation.Fda safety report id# (b)(4).

• Brand Name: ACESSA UTERINE FIBROID ABLATION DEVICE
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): ACESSA HEALTH INC. ; austin TX
• MDR Report Key: 8894215
• MDR Text Key: 154538396
• Report Number: MW5089026
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 36 YR
• Patient Weight: 96