MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-31 for STORZ * E3096 8.25 manufactured by Storz Opthalmics.
[128514]
Patient scheduled for corneal transplant of right eye. Corneal ring sutured in place and cornea scored with trephine. Physician then cut donor cornea with new trephine blade and punch; punch and trephine blade failed to cut donor cornea. Donor cornea was destroyed by the equipment. Case was cancelled. Corneal ring was removed from patient's right eye. Bleeding from suture site, antibiotic ointment and eye patch applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 217522 |
| MDR Report Key | 217522 |
| Date Received | 1999-03-31 |
| Date of Report | 1999-03-29 |
| Date of Event | 1998-08-18 |
| Date Facility Aware | 1998-08-18 |
| Report Date | 1999-03-30 |
| Date Added to Maude | 1999-04-07 |
| 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 | STORZ |
| Generic Name | TREPHINE BLADE/COTTINGHAM PUNCH |
| Product Code | HRH |
| Date Received | 1999-03-31 |
| Model Number | * |
| Catalog Number | E3096 8.25 |
| Lot Number | S1208 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 210971 |
| Manufacturer | STORZ OPTHALMICS |
| Manufacturer Address | 21 PARK PLACE BLVD NORTH CLEARWATER FL 34619 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-03-31 |