MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2014-01-16 for GENERATOR PS100-100 PULSAR manufactured by Medtronic Advanced Energy, Llc.
[4143056]
Sales rep called to report for the customer that the front of the hand piece and the wire melted and detached at the tip during use in an adenoidectomy procedure.
Patient Sequence No: 1, Text Type: D, B5
[11556003]
(b)(4). Method: generator still in use and facility not returning for investigation. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24932610]
Patient Sequence No: 1, Text Type: N, H10
[24932611]
Regulatory report was sent in error as the generator involved in this report was deemed reportable in error. Reported incident involving the generator not mdr reportable, device was deemed reportable and regulatory report associated 1226420-2014-00012.
Patient Sequence No: 1, Text Type: D, B5
[103810506]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00013 |
| MDR Report Key | 3579327 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2014-01-16 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2013-12-19 |
| Device Manufacturer Date | 2010-11-10 |
| Date Added to Maude | 2014-03-11 |
| 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 PS100-100 PULSAR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-01-16 |
| Model Number | PS100-100 |
| Catalog Number | PS100-100 |
| 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 | 2014-01-16 |