MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-04 for MEGADYNE 0118A manufactured by Megadyne Medical Products, Inc..
[63888104]
End user reported that there was current "leaking" through the insulation. We evaluated the returned sample. There were clear indications that the device had been misused. There was evidence that the electrode had not been fully inserted into the handpiece which is cautioned against in the product ifu. This is seen by residue from and alternate current route. Also, there are marks in the insulation from the use of some type of clamping instrument which damaged the insulation showed signs of residue meaning the damge was done before the device was used. This is cautioned against in our ifu. The insulation was also compressed on the device. We conclude that the device was used beyond the scope of the design of the product and contrary to the ifu for the product. This report was initially received as a problem with the insulation. We did not become aware of the patient injury until 12/02/2016.
Patient Sequence No: 1, Text Type: N, H10
[63888165]
Per customer: the surgeon noticed that tissue next to the insulated part of the surgical tip was being affected by the diathermy, immediately upon operating. Tissue next to the insulated portion of the megafine tip was damaged dur to what appeared to be current "leaking" through the insulation. The surgeon was required to make an additional suture, leaving the patient with an additional scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2017-00001 |
| MDR Report Key | 6223238 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-04 |
| Date of Report | 2016-01-03 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-12-02 |
| Date Added to Maude | 2017-01-04 |
| 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 | MR. JOHN BLIGHT |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8015769669 |
| Manufacturer G1 | MEGADYNE MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEGADYNE |
| Generic Name | EZ CLEAN ELECTRODE |
| Product Code | JOS |
| Date Received | 2017-01-04 |
| Returned To Mfg | 2016-12-20 |
| Model Number | 0118A |
| Catalog Number | 0118A |
| Lot Number | UNK |
| Operator | NURSE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-04 |