MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA GUIDANCE HANDPIECE

Model Number 5300

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

Patient Problem Fever (1858)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Device not available for investigation or testing, therefore root cause analysis of device was not possible.Hazard analysis (fa-01-0003-q.I.D.94) describes a possible hazard with packaging being compromised prior to use resulting in contamination of device and patient fever.This is highly unlikely as standard of care requires users to evaluate packaging prior to use.The ifu states do not use if product or packaging is damaged (pl-01-0033-f).Email update was received on (b)(6) 2017 from (b)(6) that stated: "currently the patient is doing well and has had no sequelae after her recovery.".

Event Description

Patient re-admitted to hospital 3 days following novasure/acessa procedure with heavy bleeding and low grade fever.While in the hospital, bleeding was controlled and patient was found to have uti.Patient was treated with anti-biotic and discharged.Patient returned 2 days later with low grade fever again.White blood cell count was elevated.Ct scan showed nothing of consequence.On (b)(6) 2017 patient discharged again.Patient woke up on (b)(6) 2017 with low grade fever and is being monitored.

• Brand Name: ACESSA GUIDANCE HANDPIECE
• Type of Device: ACESSA
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd.; bldg. 3, ste. 200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 7004 bee cave rd.; bldg. 3, ste. 200; austin TX 78746
• Manufacturer Contact: isaac rodriguez ; 7004 bee cave rd.; bldg. 3, ste. 200; austin, TX 78746 ; 5127850707
• MDR Report Key: 7131218
• MDR Text Key: 95322048
• Report Number: 3006443171-2017-00001
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2017

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: Physician
• Device Model Number: 5300
• Device Catalogue Number: 5300
• Device Lot Number: 17051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other