MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2014-07-17 for PULSAR GENERATOR MAE UNK PEAK GEN manufactured by Medtronic Advanced Energy, Llc.
[19718515]
During a tonsil and adenoidectomy case the plasmablade tna device (adenoid tip) sparked. The generator settings at the time of the spark were coag 8, cut 1, but the oxygen setting was unknown. No patient impact (patient details refused to be given by user facility). *due to the fact that the generator could not be ruled out as the cause or a contributing factor to the reported incident it is deemed reportable
Patient Sequence No: 1, Text Type: D, B5
[19858285]
Product event (b)(4). Method, results, conclusion: generator not returned therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103812033]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00051 |
| MDR Report Key | 3942008 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2014-07-17 |
| Date of Report | 2014-06-18 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2014-06-18 |
| Date Added to Maude | 2014-07-31 |
| 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 | PULSAR GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-07-17 |
| Model Number | MAE UNK PEAK GEN |
| Catalog Number | MAE UNK PEAK GEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-07-17 |