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 2016-07-27 for ACESSA GUIDANCE HANDPIECE 5300 manufactured by Halt Medical, Inc..
[50612102]
The device was not returned for evaluation (lot# 160101). (b)(6) reviewed the acessa system hazard analysis (b)(4). Review determined that this type of risk may occur (hazard analysis i. D. (b)(4)) which would result in patient burn when rf is applied and the device is not positioned correctly, in this case the accidental ablation of bladder tissue. This "thermal injury" issue is the 2nd occurrence in approximately (b)(4) cases. Each case averages 4-6 fibroid treatments, therefore, there are approximately (b)(4) ablations performed with only (b)(4) known cases of "thermal injury". The rate of frequency is considered (b)(4). In addition, we also do not know if the myomectomy procedure may have contributed to this "thermal injury" issue. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[50612103]
On (b)(6) 2016 dr. (b)(6) treated a patient for uterine fibroids with the acessa procedure at (b)(6) center, (b)(6). The patient complained of bladder symptoms and a bladder injury was diagnosed by an urologist via a cystoscopy on the inner wall of the bladder. Dr. (b)(6) contacted the sales director of (b)(6) medical on (b)(6) 2016 and notified him that his patient experience a thermal bladder injury. The patient was treated for uti and reported to be doing well. It was also noted after the acessa procedure, a decision was made to perform an abdominal myomectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2016-00003 |
| MDR Report Key | 5828247 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-27 |
| Date of Report | 2016-07-11 |
| Date of Event | 2016-06-21 |
| Date Mfgr Received | 2016-07-07 |
| Device Manufacturer Date | 2016-01-28 |
| Date Added to Maude | 2016-07-27 |
| 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 ROAD 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 ROAD. 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 GUIDANCE HANDPIECE |
| Generic Name | GUIDANCE HANDPIECE |
| Product Code | HFG |
| Date Received | 2016-07-27 |
| Model Number | 5300 |
| Catalog Number | 5300 |
| Lot Number | 160101 |
| Device Expiration Date | 2018-01-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALT MEDICAL, INC. |
| Manufacturer Address | 131 SAND CREEK ROAD SUITE B BRENTWOOD CA 94513 US 94513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-27 |