MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-07-16 for PULSAR GENERATOR MAE UNK PEAK GEN manufactured by Medtronic Advanced Energy, Llc.
[17387321]
During a tka procedure, the surgeon encountered a bleeding vessel and to provide hemostatsis the surgeon touched the plasmablade 3. 0 device to metal hemostats that were isolating the bleeding vessel. Upon contact between the plasmablade 3. 0 and the hemostats, a flame was conducted on the tip of the plasmablade 3. 0 device. Use of the plasmablade was discontinued and an alternative electrocautery device was utilized to complete the case. No patient impact reported. Note: device ifu.
Patient Sequence No: 1, Text Type: D, B5
[17813417]
Product event #(b)(4). Evaluation: (result): generator not returned (still in use) therefore analysis unable to be performed. Evaluation code (conclusion): generator not returned (still in use) therefore analysis unable to be performed. Note: device ifu (lbl-00166 rev. B) states the following: observe fire precautions at all times. An electrosurgical device may provide an ignition source due to sparking and heating. Do not contact metal objects and instruments with the peak plasmablade while power is being applied as unintended tissue damage and electrode tip damage could occur. The likely cause of the tip ignition was due to contact between the plasmablade 3. 0 device and the metal hemostat, as the device is meant to be utilized in direct contract with the tissue being treated not indirectly through the direct contact with the hemostats. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00047 |
| MDR Report Key | 3937174 |
| Report Source | 06,07 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-06-17 |
| Date of Event | 2014-06-09 |
| Date Mfgr Received | 2014-06-17 |
| Date Added to Maude | 2014-07-29 |
| 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 | PULSAR GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-07-16 |
| Model Number | MAE UNK PEAK GEN |
| Catalog Number | MAE UNK PEAK GEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-07-16 |