MAUDE Adverse Event Report: HALT MEDICAL, INC. ACESSA GUIDANCE HANDPIECE

Model Number 5300

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

Patient Problem Burn, Thermal (2530)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation (lot# 160101).(b)(6) reviewed the acessa system hazard analysis (b)(4).Review determined that this type of risk may occur (hazard analysis i.D.(b)(4)) which would result in patient burn when rf is applied and the device is not positioned correctly, in this case the accidental ablation of bladder tissue.This "thermal injury" issue is the 2nd occurrence in approximately (b)(4) cases.Each case averages 4-6 fibroid treatments, therefore, there are approximately (b)(4) ablations performed with only (b)(4) known cases of "thermal injury".The rate of frequency is considered (b)(4).In addition, we also do not know if the myomectomy procedure may have contributed to this "thermal injury" issue.Not returned to manufacturer.

Event Description

On (b)(6) 2016 dr.(b)(6) treated a patient for uterine fibroids with the acessa procedure at (b)(6) center, (b)(6).The patient complained of bladder symptoms and a bladder injury was diagnosed by an urologist via a cystoscopy on the inner wall of the bladder.Dr.(b)(6) contacted the sales director of (b)(6) medical on (b)(6) 2016 and notified him that his patient experience a thermal bladder injury.The patient was treated for uti and reported to be doing well.It was also noted after the acessa procedure, a decision was made to perform an abdominal myomectomy.

• Brand Name: ACESSA GUIDANCE HANDPIECE
• Type of Device: GUIDANCE HANDPIECE
• Manufacturer (Section D): HALT MEDICAL, INC.; 131 sand creek road; suite b; brentwood CA 94513
• Manufacturer (Section G): HALT MEDICAL, INC.; 131 sand creek road.; suite b; brentwood CA 94513
• Manufacturer Contact: lou tateo ; 131 sand creek road; suite b; brentwood, CA 94513 ; 9256347949
• MDR Report Key: 5828247
• MDR Text Key: 50612102
• Report Number: 3006443171-2016-00003
• 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: 07/11/2016

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 Expiration Date: 01/28/2018
• Device Model Number: 5300
• Device Catalogue Number: 5300
• Device Lot Number: 160101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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