MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-11-13 for PULSAR 2 GENERATOR PS100-102 manufactured by Medtronic Advanced Energy, Llc.
[5050520]
During a check of the system in biomed the unit failed the routine testing. There was high output on setting coag 5. The unit was tested three times, once with the plasmablade device and twice without. The unit was plugged into a power strip the first two times and a wall outlet the last time. There was no change in test results.
Patient Sequence No: 1, Text Type: D, B5
[12561754]
Product event # (b)(4). Evaluation, (method), (result), conclusion): generator returned for analysis and analysis results pending. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26180315]
Product analysis #700755541 complaint not confirmed lhr/dhr review: no associated manufacturing or servicing issues. Evaluation process: performed visual inspection on unit per tcl-514-900008. -unit has gouges and scratches down to the exposed metal. Performed baseline functional testing per tcl-514-900008. -no issues round. Delivered rf energy properly in all modes. Root cause: could not confirm report of low power. All modes of power were delivered within specification. The complaint noted that a tna handpiece was used to perform the test. A tna handpiece has a power setting of 40w for cut 8 and a power setting of 50w for coag 5. This suggests that the values measured by the biomed of 39. 7w for cut 8 (within 1% of target) and 48. 4w for coag 5 (within 4% of target) were actually within specification. Gouges and scratches on enclosure due to rough handling in the field.
Patient Sequence No: 1, Text Type: N, H10
[26180316]
During a check of the system in biomed the unit failed the routine testing. There was high output on setting coag 5. The unit was tested three times, once with the plasmablade device and twice without. The unit was plugged into a power strip the first two times and a wall outlet the last time. There was no change in test results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00111 |
| MDR Report Key | 4247523 |
| Report Source | 06,07 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2014-12-03 |
| Device Manufacturer Date | 2012-07-30 |
| Date Added to Maude | 2014-11-25 |
| 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 | PULSAR 2 GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-11-13 |
| Returned To Mfg | 2014-10-29 |
| 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 | 2014-11-13 |