MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA GUIDANCE HAND PIECE

Model Number 5300

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Device not available for investigation or testing, therefore root cause analysis of device was not possible.Hazard risk 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 is for users to evaluate packaging prior to use.The ifu states do not use if product or packaging is damaged (pl-01-0033-f).Communications with dr.(b)(6) continue to evaluate the patients health and dr.West has stated that currently patient is doing well.

Event Description

Patient re-admitted to hospital 10 days following novasure/acessa procedure with tender uterus and low grade fever.Patient has been on iv antibiotics and recently a pic line was administered.Fever and wbc count now down but patient still experiencing break through fevers in low 100's from time to time.

• Brand Name: ACESSA GUIDANCE HAND PIECE
• 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: 7134061
• MDR Text Key: 95375867
• Report Number: 3006443171-2017-00002
• 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: 11/01/2017

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: UNKNOWN - NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 12/20/2017
• 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
• Treatment: NOVASURE
• Patient Outcome(s): Other