MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-15 for ACESSA HANDPIECE 2000 manufactured by Halt Medical, Inc..
[48342217]
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
[48342218]
One of the 7 electrode array needles from the acessa handpiece (model number 2000, lot number t150101). Broke during a surgical procedure at (b)(6) with dr. (b)(6) and physician proctor, dr. (b)(6) from (b)(6). The event occurred during handpiece placement into a 10cm fibroid. It appears the handpiece was placed into the fibroid and the array deployed to 3cm. It was noted that the array was further deployed an additional 2cm. The array was retracted due to inability to optimally deploy beyond this point. The doctor withdrew the hand piece from patient to inspect. At that time, the hand piece was inspected and the ability to deploy was assessed. The array could not be deployed. A second handpiece was pulled from customer stock to proceed with the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2016-00001 |
| MDR Report Key | 5728100 |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-11-05 |
| 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 | 0 |
| 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 |