MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for MEGA POWER 1000 manufactured by Megadyne Medical.
[107964215]
Additional information, obtained after the initial report from (b)(6), bsn, mj, cphrm stated, "bovie pencil and monopolar endoscopic bovie plugged into outlet a. Both bovies activated simultaneously. Patient sustained a 5 mm and 3 mm burn to her anterior chest at the level of the sternal notch and left clavicle. " customer did not state degree of burn. Customer did state that burn was treated with silvadene cream and telfa. Customer did answer yes to reporting to a regulatory body but did not say to whom she reported the occurrence. Additional follow up was conducted regarding patient status. The facility indicated that they were unaware nor have they received any additional information reporting there was a scar in the area of the burn. Analysis conclusion: the complaint device was not return for evaluation. In an attempt to recreate the reported event, a company owned generator of the same model type was evaluated. During the evaluation, the team was able to plug in two monopolar device into port a simultaneously. Given the electrical design of the generator, the generator will enable one of the devices to be energized when the other is activated if both are plugged into the same port simultaneously. We did not receive a serial number for the reported device, therefore we were unable to perform a device history review.
Patient Sequence No: 1, Text Type: N, H10
[107964216]
The customer reported that during a breast augmentation procedure, the cut/coag settings were 40/40. There was a megadyne pencil in port a. They were also using an additional instrument called a endo-breast, that was also plugged into port a. The megadyne pencil, without the holster, was reportedly placed on the patient when the endo-breast instrument was activated. The megadyne pencil that was placed on the patient reportedly burned a 3 mm x 5 mm area on the chest and was described as a second degree burn. It was reported that the facility had been in serviced about where to plug in instruments and foot control devices.
Patient Sequence No: 1, Text Type: D, B5
[132413854]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721194-2018-00007 |
| MDR Report Key | 7482704 |
| Date Received | 2018-05-03 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-12-08 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-05-03 |
| 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 | STACEY CASTANEDA |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8007476110 |
| Manufacturer G1 | MEGADYNE MEDICAL PRODUCTS, INC |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEGA POWER |
| Generic Name | ELECTROSURGICAL GENERATOR |
| Product Code | DWG |
| Date Received | 2018-05-03 |
| Model Number | 1000 |
| Catalog Number | 1000 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84020 US 84020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-03 |