[21286893]
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's pieces were out for repair). This was the first time the loaner 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 thin layer of stromal fibers supporting the inner descement's membrane and the endothelial cells. The 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 in the tissue about 2/3 of the way through the cut. This created a partial flap tear in the remaining button. The remaining button was thick and irregular, estimated to be 250 microns at its thickest and 150 microns at its thinnest. The surgeon opted to continue with the procedure and the prepared donor corneal tissue was implanted into the patient's operative eye. The status/outcome of the procedure is still pending at this time. ====================== manufacturer response for artificial anterior chamber, moria======================moria plans to check loaner equipment being returned to them as well as turbine hose and keratome head. Company also requested a flap complication report they sent, to be completed for them. ====================== manufacturer response for control console, moria evolution 3 console======================moria plans to check loaner equipment being returned to them as well as turbine hose and keratome head. Company also requested a flap complication report they sent, to be completed for them. ====================== manufacturer response for miniature motor, turbine======================moria plans to check loaner equipment being returned to them as well as turbine hose and keratome head. Company also requested a flap complication report they sent, to be completed for them.
Patient Sequence No: 1, Text Type: D, B5
[21364916]
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's pieces were out for repair). This was the first time the loaner 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 thin layer of stromal fibers supporting the inner descement's membrane and the endothelial cells. The 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 in the tissue about 2/3 of the way through the cut. This created a partial flap tear in the remaining button. The remaining button was thick and irregular, estimated to be 250 microns at its thickest and 150 microns at its thinnest. The surgeon opted to continue with the procedure and the prepared donor corneal tissue was implanted into the patient's operative eye. The status/outcome of the procedure is still pending at this time. ====================== manufacturer response for artificial anterior chamber, moria======================moria plans to check loaner equipment being returned to them as well as turbine hose and keratome head. Company also requested a flap complication report they sent, to be completed for them. ====================== manufacturer response for control console, moria evolution 3 console======================moria plans to check loaner equipment being returned to them as well as turbine hose and keratome head. Company also requested a flap complication report they sent, to be completed for them. ====================== manufacturer response for miniature motor, turbine======================moria plans to check loaner equipment being returned to them as well as turbine hose and keratome head. Company also requested a flap complication report they sent, to be completed for them.
Patient Sequence No: 1, Text Type: D, B5