MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-20 for ACESSA HANDPIECE 2000 manufactured by Halt Medical Inc..
[19768671]
During the course of the investigation of a loss of thermocouple readings during a case on (b)(6) 2014, first preliminary investigation pointed to a possible simple error in manufacturing like a lack of contact point caused by, possibly, the thin wires separating from the tip, etc. It turned out on (b)(6) 2014, that the loss of the reading is due to a series of events where in there is an anatomy issue with an unstable, "rolling" fibroid which caused the physician (who was in her second case and still being proctored) to move the handpiece in and out of the fibroid, unknowingly manipulating and twisting the handpiece while partly deployed. This then caused severe stresses to the needles specially one of the needles that ended up breaking. This broken needle then jammed at the distal end causing internal stresses to the slider brackets causing it to break loose which made it conducive for the thermocouple wires to break and display no temperature readings. Therefore, the factors contributing to the root cause of the needle breaking comprised of: anatomy of the fibroid - unstable, rolling fibroid, which are usually difficult for new physicians to stabilize. A doctor who is still new to the procedure, having most likely inadvertently twisted and manipulated the handpiece while partially deployed. The same doctor continued the case with a new handpiece and this time were able to treat the fibroid without any issues. The procedure went well and there were no issues reported regarding the patient's health during or after the procedure at this time after at least about 2-3 follow-ups after the case has been completed. The proctor continues to have communications with the trainee to ensure no other issues have come up regarding the case. So far the doctor and patient related to the case has not exhibited or shown any dissatisfaction with the device or the procedure. The issue was not repeated again with this doctor in subsequent fibroid treatments.
Patient Sequence No: 1, Text Type: D, B5
[19795267]
Training program already states not to manipulate or twist, etc. When the handpiece's needles are deployed. Re-creation of the issue showed that this is a definite case factor in the needle breaking issue. This combined with the constant moving and instability of the target fibroid, caused unnecessary stresses to the device's nitinol needle, which then bent excessively to the point of breakage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006443171-2014-00002 |
| MDR Report Key | 3807271 |
| Report Source | 05,07 |
| Date Received | 2014-03-20 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-03-07 |
| Date Mfgr Received | 2014-01-29 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-06-06 |
| 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 | 2014-03-20 |
| Returned To Mfg | 2014-01-29 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | T130101 |
| ID Number | NA |
| Device Expiration Date | 2015-01-10 |
| 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 | 2014-03-20 |