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

Model Number 2000

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/01/2015

Event Type  Injury  

Event Description

Several weeks after uterine fibroid treatment at (b)(6) on (b)(6) 2015, dr.Was approached by the patient regarding her issues around (b)(6) 2015.During her treatment there were no known complications however several weeks later she complained of bladder symptoms and a bladder injury was apparently diagnosed by another doctor.He asked to have a follow-up with the patient but she decided to get treated at (b)(6) instead.There she had a urologic surgery to treat the bladder thermal injury.Dr.(b)(6) then reported this issue to halt on (b)(6) 2015.There were no detailed patient information received by halt or whether or not the patient has had other procedures before acessa or after.Note that dr.(b)(6) has performed about 95 procedures as of early (b)(6) of this year with no complications such as this.The acessa system has also been used in about 1000 procedures with this as the first known thermal injury.

Manufacturer Narrative

Although device itself cannot be evaluated, halt looked into risk assessments and found that if device was used in such a way that if the trocar/needles were deployed that it touched the bladder and may have accidentally ablated the bladder tissue.This puncture of other organs during a laparoscopic procedure is not an unknown adverse event.In the case of the acessa system, this issue has happened 1 out of about 1000 cases with each case having an average of about 4-6 fibroids being ablated.So in reality 4000 to 6000 ablations performed with only 1 case of "thermal injury".The rate of frequency is very low.In addition, we also do not know if the patient had other procedures besides the acessa.We also did not have any information or details regarding the diagnosis and urologic surgery the patient has gone through.Which made evaluation difficult.Not received; known laparoscopic risk.

• Brand Name: ACESSA HANDPIECE
• Type of Device: ACESSA 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: ms. altonaga ; 131 sand creek road suite b; brentwood, CA 94513 ; 9252710626
• MDR Report Key: 4813415
• MDR Text Key: 17206889
• Report Number: 3006443171-2015-00001
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2015

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: 2000
• Device Catalogue Number: 2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 06/02/2015
• 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): Required Intervention