MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-04-29 for GENERATOR PULSAR II PS100-102 manufactured by Medtronic Advanced Energy (salient).
[4478051]
An hour into the case, the tip of the handpiece started sparking (visible sparks coming from the tip). The handpiece's tip was red around the edge when the sparking occurred. The hand piece tip was not touching any metal within the operative field but it was a few inches from the metal forceps. After the device sparked the doctor put the handpiece down (not activated) on the surgical field. The device tip burned through the physician assistants (pa) surgical gown and burnt him. New device was obtained for use without additional reported issues. The pa treated the burn himself with some ointment and is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[11732950]
Product event # (b)(4). Evaluation process: performed visual inspection on unit per (b)(4). Unit is in good condition. Performed baseline functional testing per (b)(4). Rf energy was correctly delivered into fixed resistors. Performed an analog test with settings cut 7 and coag 7. Sparks are evident with the handpiece when not in direct contact with the tissue equivalent during coag 7 (this is normal behavior. ) the tip of the test handpiece got hot, as expected (it is in contact with either saline that it is heated in temperatures above water? S boiling point or in contact with an arc of electricity that is even hotter. ) the tip was found to be hot enough to melt a plastic bag if not allowed to cool down before placing it in contact with the plastic. Root cause: arching, or? Sparks,? Can occur when the tip of a plasmablade is activated to deliver coag energy without the tip being in direct contact with tissue. This is normal behavior. The tip of a plasmablade can get hot during use. The tip can burn surfaces if not allowed to cool down before it contacts surfaces. This is normal behavior. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20717786]
An hour into the case, the tip of the handpiece started sparking (visible sparks coming from the tip). The handpiece's tip was red around the edge when the sparking occurred. The hand piece tip was not touching any metal within the operative field but it was a few inches from the metal forceps. After the device sparked the doctor put the handpiece down (not activated) on the surgical field. The device tip burned through the physician assistants (pa) surgical gown and burnt him. New device was obtained for use without additional reported issues. The pa treated the burn himself with some ointment and is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[20960151]
(b)(4). Method results and conclusion: product received by manufacturer and pending inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86571199]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00036 |
| MDR Report Key | 3778297 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-04-29 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-04-02 |
| Date Mfgr Received | 2014-05-15 |
| Date Added to Maude | 2014-06-19 |
| 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 | KAYLEE WHITNEY |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERATOR PULSAR II |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-04-29 |
| Returned To Mfg | 2014-04-08 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY (SALIENT) |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-29 |