MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2010-03-26 for OPTEMP II 8065004603 manufactured by Alcon-houston.
[1480462]
Adverse event: burn. Malfunction: power conduction. Customer reported during a procedure to treat a small lesion on a patient's finger, the plastic from around the cautery tip melted and fell onto a gauze under the patient's finger. It caused the gauze to catch fire and burn 30% of the tip of patient's finger. Additional information is being sought.
Patient Sequence No: 1, Text Type: D, B5
[8593835]
No sample was returned for evaluation and root cause analysis. The customer's complaint history was reviewed; this is the first event reported regarding this issue for this facility. The device history records were reviewed. The lots were released based on alcon's acceptance criteria. However, 2 samples of current product were obtained from inventory for reproducing the nonconformance scenario. Two experiments were conducted, both with the goal of generating enough heat to melt the "fine tip preform" (plastic from around the cautery tip): tip filament was wiped down with the isopropyl alcohol, 70% (ipa) using standard piece of gauze. Without allowing the tip to dry completely, the optemp ii was turned on and held in the on position for approximately five (5) min. Initially the presence of ipa, with the heat of the optemp, generated a fire at the tip filament only. The flame caused the ipa to evaporate immediately (less than 30 sec) and the flame extinguished w/o human intervention. No melting was observed to this point of the experiment; therefore, with the sample still in the "on" position, the tip filament was touched to the ipa soaked gauze. This started a continuously burning flame, which later had to be extinguished using human intervention. The sample was held over the flame with the device still in the "on" position. Care was taken to hold the fine tip preform area directly in the flame. Melting could not be produced after having the sample on continuously and held to a flame for five (5) mins. The report was not duplicated with this experiment. Similar to the experiment above, all the same steps were taken, except that the filament was manually manipulated so that the tip actually touched the fine tip preform. Additionally, the 2nd experiment was altered in that unit was held in the flame until it became inoperable (approximately 10 mins. ) no melting or drops of raw material was observed during the 2nd experiment either. Once again, the customer's report could not be duplicated. See the attached picture of the tested inventory sample. The fine tip preform is constructed of high impact polystyrene resin (hips) with a melting point of 215 degrees f. The optemp ii is rated for 1300 degrees c/2372 degrees f; therefore, technically, is capable of melting the hips constructed component, however, it is indeterminable why the circumstances reported by the customer was unable to be recreated. Root cause: indeterminable; however, the supplier has been requested to report any info to alcon that may lead to determining a root cause for this issue. Corrective action: none identified, however, the incoming product will be monitored closely for any issues similar to this report. The product will continue to be monitored per alcon approved procedure and processes. (b) (4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2010-00012 |
| MDR Report Key | 1644663 |
| Report Source | 01,05,07 |
| Date Received | 2010-03-26 |
| Date of Report | 2010-02-24 |
| Date of Event | 2010-02-24 |
| Date Mfgr Received | 2010-02-24 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-04-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY R7-18 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON-HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTEMP II |
| Generic Name | UNIT, CAUTERY, THERMAL, BATTERY-POWERED |
| Product Code | HQP |
| Date Received | 2010-03-26 |
| Model Number | 8065004603 |
| Catalog Number | 8065004603 |
| Lot Number | 59894900 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON-HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-26 |