MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-01-04 for 3000 LE ND: YAG LASER manufactured by Ellex/alcon-irvine Technology Center.
[587696]
The facility reported the bulb would not work, even after changing to a different bulb. Five cases had been cancelled, including one patient that had already been prepped for surgery, with the eye open.
Patient Sequence No: 1, Text Type: D, B5
[7939619]
A company rep requested the customer reseat bulb; unit is now working.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2007-00016 |
| MDR Report Key | 804930 |
| Report Source | 05,07 |
| Date Received | 2007-01-04 |
| Date of Report | 2006-12-05 |
| Date of Event | 2006-12-01 |
| Date Mfgr Received | 2006-12-05 |
| Date Added to Maude | 2007-01-17 |
| 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 | ELLEX/ ALCON-IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PKWY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3000 LE ND: YAG LASER |
| Generic Name | LASER PHOTODISRUPTER |
| Product Code | LXS |
| Date Received | 2007-01-04 |
| Model Number | 3000 LE |
| Catalog Number | 3000 LE |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 792429 |
| Manufacturer | ELLEX/ALCON-IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PKWY. IRVINE CA 92618 US |
| Baseline Brand Name | 3000 LE ND: YAG PHOTODISRUPTER |
| Baseline Generic Name | LASER PHOTODISRUPTER |
| Baseline Model No | 3000 LE |
| Baseline Catalog No | 3000 LE |
| Baseline ID | NA |
| Baseline Device Family | P-DISRUPTER |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882772 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-04 |