MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-12 for DIRECTIONAL LASER PROBE * manufactured by Synergetics, Inc..
[4827469]
The patient is a (b)(6) gentleman with a history of proliferative diabetic retinopathy, treated with panretinal photocoagulation, and a recent vitreous hemorrhage with subhyaloid hemorrhage in the right eye. He also has a history of macular edema in the right eye. He presented for removal of vitreous hemorrhage and laser treatment in the right eye. During the laser application, the laser probe malfunctioned. It was not able to retract from the curved position, making it difficult to remove the probe through the straight 23 gauge cannula and superior nasal sclerotomy. During the attempt to remove the probe, it touched the posterior capsule of the lens, creating a hole in the posterior capsule. The 23 gauge cannula was dislodged from the sclerotomy at the time of removal. The patient is at increased risk for early cataract formation as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4088618 |
| MDR Report Key | 4088618 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-09-12 |
| Date of Event | 2014-08-27 |
| Report Date | 2014-09-12 |
| Date Reported to FDA | 2014-09-12 |
| Date Reported to Mfgr | 2014-09-15 |
| Date Added to Maude | 2014-09-15 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTIONAL LASER PROBE |
| Generic Name | PHOTOCOAGULATOR AND ACCESSORIES,DIRECTIONAL LASER PROBE |
| Product Code | HQB |
| Date Received | 2014-09-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | M209540 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS, INC. |
| Manufacturer Address | 79 HUBBLE DRIVE SUITE 107-109 COTTLEVILLE MO 63304 US 63304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-12 |