MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-11-24 for PULSAR II GENERATOR PS100-102 manufactured by Medtronic Advanced Energy, Llc.
[5224812]
During a routine preventative maintenance check of the pulsar ii generator setting cut 9 generated a high output reading. All other settings were within normal limits. The unit was plugged directly into the wall and a fluke scopemeter was used for testing. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[12542588]
Product event # (b)(4). Evaluation, (method), (result),(conclusion): pending return of product for analysis.
Patient Sequence No: 1, Text Type: N, H10
[34465314]
Product event #(b)(4) brief description of complaint: generator failed biomed testing due to high output values. Evaluation process: *performed visual inspection on unit per tcl-514-900008. -unit has scratches down to the exposed metal. -monopolar receptacle is loose: one of the two internal plastic mounting tabs is broken off. It was found wedged in a corner of the enclosure. *performed baseline functional testing per tcl-514-900008. -no issues found. Unit delivered rf energy properly in all modes. The report doesn? T state which handpiece was used for the evaluation, but cut 9 and cut 10 are generally high cut 1 and high cut 2 modes, 25w or greater. The testing performed in the service department measure the following values in those modes: 30w high cut 1: 30. 3w 50w high cut 1: 50. 4w 30w high cut 2: 29. 6w 60w high cut 2: 59. 9w it was found that power measurements in all modes were well within the required power spread of +/-20%, with the power spread for high cut1 and high cut 2 measurements, in particular, measuring within 30% of their target values. Root cause: could not replicate high output on cut 9 and cut 10: unit generated rated power within permissible power spread in all modes. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34465315]
During a routine preventative maintainence check of the pulsar ii generator setting cut 9 generated a high output reading. All other settings were within normal limits. The unit was plugged directly into the wall and a fluke scopemeter was used for testing. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00112 |
| MDR Report Key | 4272014 |
| Report Source | 06,07 |
| Date Received | 2014-11-24 |
| Date of Report | 2015-02-16 |
| Date of Event | 2014-09-30 |
| Date Mfgr Received | 2015-02-16 |
| Device Manufacturer Date | 2012-09-06 |
| Date Added to Maude | 2014-12-04 |
| 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 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSAR II GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-11-24 |
| Returned To Mfg | 2014-11-26 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| Device Expiration Date | 2019-09-06 |
| 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 | 2014-11-24 |