MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-15 for ACESSA HANDPIECE 2000 manufactured by Halt Medical, Inc..
[47496504]
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.
Patient Sequence No: 1, Text Type: N, H10
[47496585]
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 The handpiece was retracted after completion of that treatment and inspected both laparoscopically and outside of the patient for potential damage to needle #7.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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2016-00002 |
| MDR Report Key | 5728101 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2015-01-23 |
| Date Added to Maude | 2016-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LOU TATEO |
| Manufacturer Street | 131 SAND CREEK RD. SUITE B |
| Manufacturer City | BRENTWOOD CA 94513 |
| Manufacturer Country | US |
| Manufacturer Postal | 94513 |
| Manufacturer Phone | 9256347949 |
| Manufacturer G1 | HALT MEDICAL, INC. |
| Manufacturer Street | 131 SAND CREEK RD. SUITE B |
| Manufacturer City | BRENTWOOD CA 94513 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACESSA HANDPIECE |
| Generic Name | ACESSA HANDPIECE |
| Product Code | HFG |
| Date Received | 2016-06-15 |
| Returned To Mfg | 2016-05-18 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | T150101 |
| Device Expiration Date | 2017-01-23 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALT MEDICAL, INC. |
| Manufacturer Address | 131 SAND CREEK RD. SUITE B BRENTWOOD CA 94513 US 94513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-15 |