MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-19 for MORIA EVOLUTION 3 CONSOLE * 19360 manufactured by Moria Inc..
[1065081]
The scheduled procedure involved in the incident was a dsaek (descemet's stripping automated epithelial keratoplasty). The incident occurred during the preparation of the donor tissue that was to be used for implantation. The equipment used for the cutting of the donor cornea was: 1. Moria evolution 3 console 2. Moria turbine, turbine hose, 300 microkeratome head, disposable microkeratome blade. 3. Artificial chamber. Both the console and turbine were "loaner" pieces from moria. (facility pieces were out for repair). This was the 2nd time the loan equipment was used. Pre-op tests on the systems were completed without any problems noted. The following explains the dynamics of donor preparation. An artificial anterior chamber is used to support the donor cornea while it is being cut with a microkeratome (miniature motorized cutting device). The microkeratome skims off the outer layers of the cornea leaving a very thick layer of stromal fibers supporting the inner descemet's membrane and the endothelial cells. This remaining thin layer is what is implanted into the patient's operative eye. Normally, the microkeratome cuts the donor cornea in a smooth, regular forward movement. According to the surgeon, the intended thickness of the cut was 300 microns. The blade of the microkeratome became hung up about 1/3 of the way through the cut which yielded a posterior graft that was about 150 microns at its thinnest and about 450 - 500 microns at its thickest. The surgeon opted to continue with the procedure and the prepared donor corneal tissue was implanted into the patient's operative eye. Note: approximately one week later the patient was scheduled for a repeat dsaek due to failed graft. Pre-cut corneal tissue from eye bank used. Outcome pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1354341 |
| MDR Report Key | 1354341 |
| Date Received | 2009-03-19 |
| Date of Report | 2009-03-19 |
| Date of Event | 2009-03-11 |
| Report Date | 2009-03-19 |
| Date Reported to FDA | 2009-03-19 |
| Date Added to Maude | 2009-04-03 |
| 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 |
| 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 | MORIA EVOLUTION 3 CONSOLE |
| Generic Name | CONTROL CONSOLE |
| Product Code | HNO |
| Date Received | 2009-03-19 |
| Returned To Mfg | 2009-03-19 |
| Model Number | * |
| Catalog Number | 19360 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORIA INC. |
| Manufacturer Address | 1050 CROSSKEYS DRIVE DOYLESTOWN PA 18901 US 18901 |
| Brand Name | TURBINE |
| Generic Name | MINIATURE MOTOR |
| Product Code | HNO |
| Date Received | 2009-03-19 |
| Returned To Mfg | 2009-03-19 |
| Model Number | CB |
| Catalog Number | 19303 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MORIA INC |
| Manufacturer Address | 1050 CROSSKEYS DRIVE DOYLESTOWN PA 18901 US 18901 |
| Brand Name | CBM BLADE |
| Generic Name | MICROKERATOME BLADE - DISPOSABLE |
| Product Code | HNO |
| Date Received | 2009-03-19 |
| Model Number | * |
| Catalog Number | 19333 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MORIA INC. |
| Manufacturer Address | 1050 CROSSKEYS DRIVE DOYLESTOWN PA 18901 US 18901 |
| Brand Name | MORIA |
| Generic Name | ARTIFICIAL ANTERIOR CHAMBER |
| Product Code | HQX |
| Date Received | 2009-03-19 |
| Returned To Mfg | 2009-03-19 |
| Model Number | * |
| Catalog Number | 19161 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 3 YR |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | MORIA INC. |
| Manufacturer Address | 1050 CROSSKEYS DRIVE DOYLESTOWN PA 18901 US 18901 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-19 |