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 PULSAR REFURBISHED PS100-100RF manufactured by Medtronic Advanced Energy, Llc.
[5212043]
During routine biomed testing of the pulsar generator and plasmablade cut levels 1-5 were higher than the expected output value. All other settings were within specifications. An rf 303 biotech esu was used for testing with a 3. 0 device. There were no error codes. The unit was plugged directly into the wall for testing. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[12667300]
Product event # (b)(4). Evaluation, (method, (result), (conclusion): generator returned and pending analysis results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38444575]
(b)(4) evaluation process: unit received in standard shipping container. Unit received in poor condition with case staining and gouges. No power cord nor user manual were received with unit. Two plasmablade 3. 0 handpieces were received. Internal visual inspection found nothing moving or broken in unit. Unit delivered rf energy correctly into fixed resistors. All peak cut levels were well within specified tolerances. Unit also tested with supplied handpiece with satisfactory results for cuts 1-5. Error log indicates that the ucb real-time clock died on or after (b)(6) 2014. Root cause: the reported complaint could not be replicated by the service department; unit delivered correct levels of rf energy in all modes and power levels (including cut 1-5. ) case staining is due to the use of aggressive cleaning agents in the field. Ucb real-time clock battery died due to age.
Patient Sequence No: 1, Text Type: N, H10
[38444576]
During routine biomed testing of the pulsar generator and plasmablade cut levels 1-5 were higher than the expected output value. All other settings were within specifications. An rf 303 biotech esu was used for testing with a 3. 0 device. There were no error codes. The unit was plugged directly into the wall for testing. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00123 |
| MDR Report Key | 4329031 |
| Report Source | 06,07 |
| Date Received | 2014-12-15 |
| Date of Report | 2015-04-03 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2015-04-03 |
| 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 PULSAR REFURBISHED |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-12-15 |
| Returned To Mfg | 2014-12-02 |
| Model Number | PS100-100RF |
| Catalog Number | PS100-100RF |
| 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 |