MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2010-03-31 for ALCON OPTEMP II CAUTERY 8065004603 manufactured by Medtronic Xomed, Inc..
[20511304]
During a diathermy on a wart, the patient received a burn on the right middle finger.
Patient Sequence No: 1, Text Type: D, B5
[20703454]
This product was being used for treatment, not diagnosis. Alcon stated to medtronic that the product in question will not be returned for analysis. Without a product analysis, it cannot be determined if the cautery met product specification. The patient's current or long term prognosis was not released to medtronic. The only conclusion is that the patient received a burn to the tip of middle finger on the right hand. (b) (6). The available information indicates the event date was on or before (b) (6) 2010. The two event descriptions provided were as follows: during diathermy on a wart on a patient's finger, the tip of the optemp caught fire and plastic dripped onto the pt's finger causing a burn. Remove a small lesion from a pt's finger, the plastic from around the cautery tip melted and fell onto standard surgical gauze under the patient's finger and caused the gauze to catch fire and burn 30% of the tip of the patient's finger. " alcon manufacturing was questioned "what preparation agents were used? " and the reply was only that "no alcohol preparations were used". Ifu 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 patient 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 patient injury. A review of the available complaint history indicates that there are no similar reports for this product family. No anomalies or non-conformances were found in the manufacturing records for this lot. (b) (4) product "alcon optemp ii high temperature sterile disposable cautery". (b) (4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2010-00012 |
| MDR Report Key | 1648165 |
| Report Source | 01,05,06,08 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-03-03 |
| Date Mfgr Received | 2010-03-04 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-04-05 |
| 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 | 0 |
| 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 | ALCON OPTEMP II CAUTERY |
| Generic Name | 86HQP |
| Product Code | HQP |
| Date Received | 2010-03-31 |
| Model Number | 8065004603 |
| Catalog Number | 8065004603 |
| Lot Number | 59894900 |
| ID Number | NA |
| Device Expiration Date | 2011-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | R |
| 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. Deathisabilit | 2010-03-31 |