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

Model Number 2000

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2014

Event Type  malfunction  

Event Description

One of the 7 electrode needle from the acessa handpiece (model number 2000, lot number t130901) broke during use in a surgical training procedure at (b)(6) hospital with dr (b)(6).Dr (b)(6), the trainer, stated that the event occured because of miscommunication between him and dr.(b)(6) on handling the device.Dr (b)(6) was having issues with stabilization of the uterus and vigorously tried to withdraw the device from the fibroid, pushing it in and out several times resulting in severe bending of a needle and breaking it.The broken part of the needle was easily grasped and removed from the fibroid and this event did not result in any pt injury or cause bleeding.The procedure continued with a new device successfully once dr (b)(6) was made aware of how to handle the device appropriately.

Manufacturer Narrative

No remedial or corrective action was initiated because the training procedure, presentation, manual, etc.Did describe such events and prevention of such events.Since no other physicians have had this experience among those trained to use the acessa system, this was considered an isolated case.Note also that this case was only the second case of dr (b)(6).Therefore, he was still being proctored by dr (b)(6), the reporting physician and trainer.Dr (b)(6) had felt that the miscommunication during surgery was the reason for the event and once that was cleared up, when another acessa device was used, the result was successful with no issues.(b)(6) in an e-mail to halt to one of the sales reps later stated that the pt was doing very well and was very thankful to be treated by the procedure.Both the doctor and the pt perceived the case to be a success event with this issue.

• 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 Contact: clarisa tate ; 131 sand creek road; suite b; brentwood, CA 94513 ; 9252710626
• MDR Report Key: 3750341
• MDR Text Key: 20856467
• Report Number: 3006443171-2014-00001
• 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: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: T130901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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