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

Model Number 2000

Device Problem Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

The corrective action shall focus on reinforcement of current language in the user training material/ifu with regards to advancing the device while array is deployed.Note that this was a training case; therefore, the doctor was still being proctored.

Event Description

See mfr.Report #3006443171-2016-00001.The same doctor continued the case with a 2nd handpiece (model number 2000, lot number t150101).The 10cm fibroid was treated numerous times.During one of the ablations, it was noted in the midst of the treatment that a temperature reading was missing from needle #7.The handpiece was retracted after completion of that treatment and inspected both laparoscopically and outside of the patient for potential damage to needle #7.At that time, needle #7 was not extending along with the other 6 needles, indicating a possible breakage in the needle similar to the first handpiece.A third handpiece was pulled from customer stock (model number 2000, lot number t150101) to complete the procedure on the second fibroid.No issues were encountered with the third handpiece.

• Brand Name: ACESSA HANDPIECE
• Type of Device: ACESSA HANDPIECE
• Manufacturer (Section D): HALT MEDICAL, INC.; 131 sand creek rd.; suite b; brentwood CA 94513
• Manufacturer (Section G): HALT MEDICAL, INC.; 131 sand creek rd.; suite b; brentwood CA 94513
• Manufacturer Contact: lou tateo ; 131 sand creek rd.; suite b; brentwood, CA 94513 ; 9256347949
• MDR Report Key: 5728101
• MDR Text Key: 47496504
• Report Number: 3006443171-2016-00002
• 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: Other
• Type of Report: Initial
• Report Date: 06/06/2016

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: Physician
• Device Expiration Date: 01/23/2017
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: T150101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• 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