MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-10-21 for SURGITRON FFPF OPHTHALMOLOGY OP110 manufactured by Ellman Int'l Inc..
[980320]
Physician reported that he was performing a blephorplasty roughly 18 mos ago. At the end of the procedure, he realized that he had cut through the pt's cornea during the procedure. He stated that there was nothing wrong with his surgitron, he simply cut too deep. The pt required a cornea transplant and now has 20/20 vision. The doctor has continued to perform blephorplasty procedures with his surgitron following the accident 18 mos ago. The instructions for use state that eye shields should be used when performing blephorplasty procedures. The physician was encouraged to use corneal shields in the future.
Patient Sequence No: 1, Text Type: D, B5
[8217521]
We haven't been able to confirm the serial number, however, our records indicate that the physician has a surgitron ffpf ohthalmology, manufactured prior to year 2002.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2428235-2008-00005 |
| MDR Report Key | 1206057 |
| Report Source | 05,06 |
| Date Received | 2008-10-21 |
| Date of Report | 2008-09-26 |
| Date of Event | 2007-03-30 |
| Date Mfgr Received | 2008-09-26 |
| Date Added to Maude | 2008-10-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICK EPSTEIN |
| Manufacturer Street | 3333 ROYAL AVENUE |
| Manufacturer City | OCEANSIDE NY 11572 |
| Manufacturer Country | US |
| Manufacturer Postal | 11572 |
| Manufacturer Phone | 5165943333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGITRON |
| Product Code | HQR |
| Date Received | 2008-10-21 |
| Model Number | FFPF OPHTHALMOLOGY |
| Catalog Number | OP110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1255021 |
| Manufacturer | ELLMAN INT'L INC. |
| Manufacturer Address | 3333 ROYAL AVENUE OCEANSIDE NY 11572 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-21 |