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 2014-12-22 for GENERATOR PULSAR II PS100-102 manufactured by Medtronic Advanced Energy, Llc.
[5199738]
While tonsil tip was being used the surgeon complained that the tonsil tip was wearing out and the tip was not rigid enough to control. The doctor felt the lack of control of the tip caused unintended thermal damage to the surrounding tissue. During the adenoid portion of the procedure the plastic housing of the adenoid tip melted. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12616762]
Eval code method, results and conclusion: generator still in use and facility not returning for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86568690]
Corrected information: no eval explain code. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00128 |
| MDR Report Key | 4349712 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-22 |
| Date of Report | 2014-11-23 |
| Date of Event | 2014-11-18 |
| Date Mfgr Received | 2014-11-23 |
| Date Added to Maude | 2015-01-08 |
| 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 | 2014-12-22 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| 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 | 2014-12-22 |