MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-10-09 for GENERATOR PULSAR II PS100-102 manufactured by Medtronic Advanced Energy (salient).
[4932932]
During a routine preventative maintenance check, the biomed department at the hospital reported that the generator was found to have high output on cut 4 and cut 5. All other settings were within specification. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12246434]
(b)(4). Method: product received by manufacturer and pending inspection. Results: product received by manufacturer and pending inspection. Conclusion: product received by manufacturer and pending inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33802576]
Product analysis #208952363 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 reported. Unit delivered correct levels of rf energy to rated loads in all modes and across all power levels. Root cause: report of higher than rated cut output power for cut levels 4 and 5 could not be confirmed in the service department. The unit delivered prescribed power (within 20% tolerance) to rated loads in all modes across all power levels. The scratches on the enclosure paint down to the exposed metal are due to rough handling in the field. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33802577]
During a routine preventative maintenance check, the biomed department at the hospital reported that the generator was found to have high output on cut 4 and cut 5. All other settings were within specification. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
[103813431]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00094 |
| MDR Report Key | 4154652 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-10-09 |
| Date of Report | 2015-01-09 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2015-01-09 |
| Date Added to Maude | 2014-10-21 |
| 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 | 2014-10-09 |
| Returned To Mfg | 2014-09-26 |
| 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 | 2014-10-09 |