MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-10-16 for GENERATOR PULSAR II PS100-102 manufactured by Medtronic Advanced Energy (salient).
[5020367]
During a routine preventative maintenance check, the facility's biomed department reported that the unit was found to have high output on coag 6. All other settings were fine. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12256385]
(b)(4). Method/results/conclusion: product returned and analysis results pending.
Patient Sequence No: 1, Text Type: N, H10
[33803698]
Product analysis #700727913 evaluation process: performed visual inspection on unit per tcl-514-900008. -unit has a dent on the rear of enclosure. -unit has scratches in the enclosure paint. -unit has numbers written on the side of the enclosure with permanent, black marker. Performed baseline functioned testing per tcl-514-900008. -no issues found. Unit delivered correct levels of rf energy in all modes across all energy levels. Specifically (amongst other settings) the unit was configured to deliver 30w of spray coagulation energy to a 500-ohm non-inductive resistor [this corresponds to coagulation setting? 6? On a 3. 0s handpiece. ] the unit was measured to deliver 30. 26w of output power, less than 1% higher than the target output power and well within allowable tolerance of +/- 20%. Root cause: could not confirm complaint of high output power for coag 6 (3. 0s handpiece. ) the unit delivers output power within 20% of the target values in all modes, across all power levels, in the service department. Dent and scratches on the enclosure are due to rough handling in the field. Numbers (permanent black marker) were written on the enclosure while in the field.
Patient Sequence No: 1, Text Type: N, H10
[33803699]
During a routine preventative maintenance check, the facility's biomed department reported that the unit was found to have high output on coag 6. All other settings were fine. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
[103813525]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00100 |
| MDR Report Key | 4176324 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-10-16 |
| Date of Report | 2015-01-09 |
| Date of Event | 2014-09-17 |
| Date Mfgr Received | 2015-01-09 |
| Date Added to Maude | 2014-10-30 |
| 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 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 II |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-10-16 |
| Returned To Mfg | 2014-10-10 |
| 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 | 2014-10-16 |