MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-15 for GENERATOR PS100-102 PULSAR II manufactured by Medtronic Advanced Energy, Llc.
[5135216]
During routine biomed testing with a fluke analyzer and plasmablade 3. 0s, the output on cut setting 6 is higher than the expected output value. Plasmablade was used on another unit to test and output values met specified guidelines. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[12739856]
Product event (b)(4). Evaluation (method): generator returned and pending analysis results. Evaluation (result): generator returned and pending analysis results. Evaluation (conclusion): generator returned and pending analysis results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35151078]
Product event # (b)(4). Evaluation process: performed visual inspection on unit per tcl-514-900008. -unit has scratches down to the exposed metal. Performed baseline functional testing per tcl-514-900008. No issues found. Unit delivered correct levels of rf energy in all modes. Cut level 6 with a 3. 0s handpiece commands the pulsar ii to deliver 20w of medium cut to rated load (40ohm. ) the report that the output measured 25w means that the output power was 25% higher than rated power(this exceeds the maximum allowable difference of 20% and is the reason or the complaint. ) the incoming inspection for the pulsar ii tested the unit across a range of power issues when delivering any mode, including medium cut, to rated load in the service department. The complaint could not be confirmed. Root cause: service department could not replicate reported discrepancy: unit delivered correct levels of rf energy in all modes, including medium cut (the mode identified in the complaint. ) scratches on the enclosure paint are due to rough handling in the field. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35151079]
During routine biomed testing with a fluke analyzer and plasmablade 3. 0s, the output on cut setting 6 is higher than the expected output value. Plasmablade was used on another unit to test and output values met specified guidelines. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00124 |
| MDR Report Key | 4329137 |
| Report Source | 06,07 |
| Date Received | 2014-12-15 |
| Date of Report | 2015-04-10 |
| Date of Event | 2014-11-18 |
| Date Mfgr Received | 2015-04-10 |
| Date Added to Maude | 2014-12-29 |
| 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 PS100-102 PULSAR II |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-12-15 |
| Returned To Mfg | 2014-12-09 |
| 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, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-15 |