MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-08 for GENERATOR PULSAR REFURBISHED PS100-100RF manufactured by Medtronic Advanced Energy, Llc.
[18711686]
(b)(4). Evaluation process: unit received in standard shipping box, in good condition. No power cord, user manual, or handpieces were received with the unit. Internal visual inspection found nothing missing or broken in unit. Handpiece functionality was faulty; cut button would not operate generator. Coag button would activate generator but energy delivery would not shut off when button released. When using the footswitch instead of the handpiece for activation the unit delivered rf energy correctly into fixed resistors. Troubleshooting revealed that component c154 on the rf amp pcba has a faulty solder joint: the coag button signal voltage could be forced to switch between its expected (unactivated) value to about half of its expected value by flexing the rf amp pcba. When the signal was at its half-voltage value, cut button closures were found to be ignored. Coag button closures were found to cause the signal to drop to its fully-closed value (thereby activating coag output). Releasing the coag button caused the signal to rise back to the half-voltage value, which was not recognized as a button release. Removing the old solder from c154, cleaning the pads, and then resoldering the part resolved the issue. Root cause: faulty solder connection of capacitor c154 on the rf amp pcba caused the described behavior. This behavior was spurious; the problem could be made to appear/disappear by flexing the pcb. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[18792313]
No surgery involved (outside surgical environment) initially reported that the generator failed to initialize, but via additional information obtained the generator turns on, screen lights up, and unit completes its self-test successfully. A test handpiece would not cut when activated and the generator did not show cut mode as active. Instead, coag mode would activate and would not stop showing as active on the generator when the handpiece activation button was released and rf energy continued to be delivered from the system (generator and device). Unit had to be restarted for coag to stop showing as active on the generator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00043 |
| MDR Report Key | 3919515 |
| Report Source | 07 |
| Date Received | 2014-07-08 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-06-24 |
| Device Manufacturer Date | 2010-12-27 |
| Date Added to Maude | 2014-07-23 |
| 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 | KAYLEE BOISVERT |
| 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 REFURBISHED |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-07-08 |
| Returned To Mfg | 2014-06-25 |
| Model Number | PS100-100RF |
| Catalog Number | PS100-100RF |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-08 |