MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-01-31 for ACESSA HANDPIECE 2000 manufactured by Halt Medical, Inc..
[20856467]
One of the 7 electrode needle from the acessa handpiece (model number 2000, lot number t130901) broke during use in a surgical training procedure at (b)(6) hospital with dr (b)(6). Dr (b)(6), the trainer, stated that the event occured because of miscommunication between him and dr. (b)(6) on handling the device. Dr (b)(6) was having issues with stabilization of the uterus and vigorously tried to withdraw the device from the fibroid, pushing it in and out several times resulting in severe bending of a needle and breaking it. The broken part of the needle was easily grasped and removed from the fibroid and this event did not result in any pt injury or cause bleeding. The procedure continued with a new device successfully once dr (b)(6) was made aware of how to handle the device appropriately.
Patient Sequence No: 1, Text Type: D, B5
[21298472]
No remedial or corrective action was initiated because the training procedure, presentation, manual, etc. Did describe such events and prevention of such events. Since no other physicians have had this experience among those trained to use the acessa system, this was considered an isolated case. Note also that this case was only the second case of dr (b)(6). Therefore, he was still being proctored by dr (b)(6), the reporting physician and trainer. Dr (b)(6) had felt that the miscommunication during surgery was the reason for the event and once that was cleared up, when another acessa device was used, the result was successful with no issues. (b)(6) in an e-mail to halt to one of the sales reps later stated that the pt was doing very well and was very thankful to be treated by the procedure. Both the doctor and the pt perceived the case to be a success event with this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006443171-2014-00001 |
| MDR Report Key | 3750341 |
| Report Source | 05,07 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-23 |
| Date of Event | 2014-01-10 |
| Date Mfgr Received | 2014-01-15 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-05-12 |
| 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 | CLARISA TATE |
| Manufacturer Street | 131 SAND CREEK ROAD SUITE B |
| Manufacturer City | BRENTWOOD CA 94513 |
| Manufacturer Country | US |
| Manufacturer Postal | 94513 |
| Manufacturer Phone | 9252710626 |
| 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 | 2014-01-31 |
| Returned To Mfg | 2014-01-15 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | T130901 |
| ID Number | NA |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-01-31 |