MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-02 for ACESSA HANDPIECE 2000 manufactured by Halt Medical, Inc..
[17206889]
Several weeks after uterine fibroid treatment at (b)(6) on (b)(6) 2015, dr. Was approached by the patient regarding her issues around (b)(6) 2015. During her treatment there were no known complications however several weeks later she complained of bladder symptoms and a bladder injury was apparently diagnosed by another doctor. He asked to have a follow-up with the patient but she decided to get treated at (b)(6) instead. There she had a urologic surgery to treat the bladder thermal injury. Dr. (b)(6) then reported this issue to halt on (b)(6) 2015. There were no detailed patient information received by halt or whether or not the patient has had other procedures before acessa or after. Note that dr. (b)(6) has performed about 95 procedures as of early (b)(6) of this year with no complications such as this. The acessa system has also been used in about 1000 procedures with this as the first known thermal injury.
Patient Sequence No: 1, Text Type: D, B5
[17524790]
Although device itself cannot be evaluated, halt looked into risk assessments and found that if device was used in such a way that if the trocar/needles were deployed that it touched the bladder and may have accidentally ablated the bladder tissue. This puncture of other organs during a laparoscopic procedure is not an unknown adverse event. In the case of the acessa system, this issue has happened 1 out of about 1000 cases with each case having an average of about 4-6 fibroids being ablated. So in reality 4000 to 6000 ablations performed with only 1 case of "thermal injury". The rate of frequency is very low. In addition, we also do not know if the patient had other procedures besides the acessa. We also did not have any information or details regarding the diagnosis and urologic surgery the patient has gone through. Which made evaluation difficult. Not received; known laparoscopic risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006443171-2015-00001 |
| MDR Report Key | 4813415 |
| Report Source | 05,07 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-03-01 |
| Date Mfgr Received | 2015-05-01 |
| Date Added to Maude | 2015-06-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ALTONAGA |
| Manufacturer Street | 131 SAND CREEK ROAD SUITE B |
| Manufacturer City | BRENTWOOD CA 94513 |
| Manufacturer Country | US |
| Manufacturer Postal | 94513 |
| Manufacturer Phone | 9252710626 |
| 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 HANDPIECE |
| Generic Name | ACESSA HANDPIECE |
| Product Code | HFG |
| Date Received | 2015-06-02 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | UNKNOWN |
| 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 | 1. Required No Informationntervention | 2015-06-02 |