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 2003-02-14 for OPTEMP II 8065004603 manufactured by Alcon - Houston.
[16792933]
Reporter noted while completing a minor surgical procedure with ophthalmic cautery in right hand, surgeon felt a sharp pain on the radial aspect of right small digit, left index and small finger (radially). Sparks, smoke and the 4x4 gauze ignited. Pt had a 4cm x 2. 5cm burn to their back; area was very red. No intervention required, but surgeon felt this could cause injury if it recurs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2003-00003 |
| MDR Report Key | 444016 |
| Report Source | 01,05,07 |
| Date Received | 2003-02-14 |
| Date of Report | 2003-01-16 |
| Date of Event | 2003-01-15 |
| Date Mfgr Received | 2003-01-16 |
| Date Added to Maude | 2003-02-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTEMP II |
| Generic Name | CAUTERY |
| Product Code | HQP |
| Date Received | 2003-02-14 |
| Returned To Mfg | 2003-01-27 |
| Model Number | OPTEMP II |
| Catalog Number | 8065004603 |
| Lot Number | 24184900 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 432994 |
| Manufacturer | ALCON - HOUSTON |
| Manufacturer Address | 2650 WEST BELLFORT HOUSTON TX 770545008 US |
| Baseline Brand Name | OPTEMP II |
| Baseline Generic Name | OPTEMP |
| Baseline Model No | OPTEMP II |
| Baseline Catalog No | 8065004603 |
| Baseline ID | NA |
| Baseline Device Family | UNIT, CAUTERY, THERMAL, BATTERY POWERED |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K820157 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-02-14 |