MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for ALCON, ENGAUGE 8065751114 manufactured by Alcon Laboratories, Inc..
[178577792]
During procedure, it was discovered that a flexible tip laser probe did not have an aiming beam and no laser. After all connections were double checked, another package was opened and used without issue. This was discovered prior to use on patient and did not cause any delays in the procedure. No harm came to the patient. Manufacturer response for photocoagulator and accessories, alcon, engauge (per site reporter). The local representative was notified and will file a complaint with alcon. The device will be returned for failure analysis upon request.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693602 |
| MDR Report Key | 9693602 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-22 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON, ENGAUGE |
| Generic Name | PHOTOCOAGULATOR AND ACCESSORIES |
| Product Code | HQB |
| Date Received | 2020-02-11 |
| Model Number | 8065751114 |
| Lot Number | 13CAAV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 S FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |