MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2010-06-16 for ACCU-TEMP CAUTERY 4882000 8442000 manufactured by Medtronic Xomed, Inc..
[1409626]
During eye surgery (conjunctive coagulation in the right eye), the pt sustained superficial burns on the cheek and the neck when it was described that "a flame went over the face, the drapes and in the nasal fosse". Both the cheek and neck are getting better. The burns in the nasal fosse required plastic cylinders to prevent adhesions. The pt still has not made a full recovery in the olfactive area and the cornea is still uncertain. It has been reported that the general state of pt is good.
Patient Sequence No: 1, Text Type: D, B5
[8622257]
The lot in question was mfg with no anomalies and without non-conformances. Electrical and functional inspection showed that the resistance and voltage of the device was within spec. Visual inspection under a microscope showed no damage or defect to any portion of the device. The product analysis concludes that the device was performing to spec. Additional info from the facility indicated oxygen was used during this procedure, the device was used in close proximity of flammable materials, and water based preparatory agents were not used as directed. A local anesthetic was used, however, the type and / or name was not disclosed. The instructions for use statements include but are not limited to the following statements; fire warning: heat generated by the tip can ignite flammable materials. Do not use in the presence of flammable materials such as facial hair, preparation agents, alcohol vapors, drapes, or gowns. Use of the device in an oxygen enriched atmosphere (e. G. Anesthesia) above 21% oxygen concentration can cause fuel sources to ignite, resulting in pt injury. Proper surgical technique, such as the application of water-based lubricant to facial hair near the surgical site of electrocautery use, must be followed to prevent potential pt injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2010-00023 |
| MDR Report Key | 1729887 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2010-06-16 |
| Date of Report | 2010-05-17 |
| Date of Event | 2010-05-17 |
| Date Facility Aware | 2010-05-17 |
| Date Mfgr Received | 2010-05-17 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2010-06-22 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-TEMP CAUTERY |
| Generic Name | HQP - UNIT, CAUTERY, THERMAL, BATTERY-POWERED |
| Product Code | HQP |
| Date Received | 2010-06-16 |
| Returned To Mfg | 2010-06-03 |
| Model Number | 4882000 |
| Catalog Number | 8442000 |
| Lot Number | 65142000 |
| ID Number | NA |
| Device Expiration Date | 2013-12-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-16 |