MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-11-20 for OPHTHALAS 532 EYELITE manufactured by Alcon-irvine Technology Center.
[296099]
Reporter noted laser shut off during use. Service request message appeared and system could not be restarted. Changed lasers to complete case. Pt was under anesthesia during a forty-five minute delay. No injury, but surgeon felt this could cause a major problem if it recurs. Pt condition reported as guarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2003-00220 |
| MDR Report Key | 498746 |
| Report Source | 05,07 |
| Date Received | 2003-11-20 |
| Date of Report | 2003-10-21 |
| Date of Event | 2003-10-21 |
| Date Mfgr Received | 2003-10-21 |
| Date Added to Maude | 2003-12-03 |
| 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 | 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 | ALCON-IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPHTHALAS 532 EYELITE |
| Generic Name | LASER PHOTOCOAGULATOR |
| Product Code | HQB |
| Date Received | 2003-11-20 |
| Model Number | 532 EYELITE |
| Catalog Number | 532 EYELITE |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 487494 |
| Manufacturer | ALCON-IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PKWY. IRVINE CA 92618 US |
| Baseline Brand Name | OPHTHALAS 532 EYELITE |
| Baseline Generic Name | LASER PHOTOCOAGULATOR |
| Baseline Model No | 532 EYELITE |
| Baseline Catalog No | 532 EYELITE |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-20 |