MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-18 for ALCON manufactured by Alcon Surgical.
[3127556]
Handle and fiber optics for shielded bullett endo illuminator separate while being used for patient care. This has occurred at least 8 times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029083 |
| MDR Report Key | 2978473 |
| Date Received | 2013-02-18 |
| Date of Report | 2013-02-18 |
| Date Added to Maude | 2013-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON |
| Generic Name | SHIELDED BULLET ENDO ILLUMINATOR PRODUCT 8065109203 |
| Product Code | HQB |
| Date Received | 2013-02-18 |
| Returned To Mfg | 2013-02-01 |
| Lot Number | 901490M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON SURGICAL |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134209 US 76134 2099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-18 |