MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-09 for MORIA EVOLUTION 3 TURBINE CB 19303 manufactured by Moria.
[21319769]
As a threshold matter, moria does not believe that these incidents were or are reportable, as the evolution 3 console device is not used directly on pts. Rather it is used to cut tissue from donor eyes for use in corneal transplants. If the tissue specimen is flawed in any way, the physician should not proceed with the transplant procedure. Therefore, there should be no risk to pts from an imperfect cut of donor tissue. It is unclear why the physician performed surgery with imperfect specimens in this case. That said, moria has conducted a thorough review and investigation of the medwatch reports filed by (b) (6) hospital, and hereby submits this response. This medical device report is written in response to two medwatch reports filed by (b) (6) hospital in (b) (6) (uf/importer report (b) (4)). Moria received copies of these reports on 04/03/2009. The reports state in both cases, the physician decided to continue with the procedure and implant the imperfectly-cut tissue into each pt's operative eye. According to (b) (6) hospital, both pts required a second dsaek procedure to replace the implanted corneal tissue with pre-cut, eye bank tissue and are now doing well. (b) (6) hospital returned turbine # (b) (4), the turbine involved in both incidents, to moria for eval. The hospital did not, however, save and return the microkeratome blade(s) used in the incidents. Moria's inspection of the equipment reveals that there was a microscopic imperfection in the threads on the back of the turbine, which led to an insecure connection between the turbine and the turbine hose, leading to a loss of power that adversely affected the quality of the corneal cut. Further eval of a "control" turbine hose confirmed that the threading imperfection was an issue only with the particular hose used in the two incidents, and is not a problem for other hoses tested on this machine. It is possible that damage to the threading occurred either during the shipping process or in the hospital facility. To moria's knowledge, the problem with the threading on the back of the loaner turbine, and (b) (6) hospital's experiences with the device, are isolated incidents that do not present quality control issues. Moria's eval also strongly suggests that (b) (6) hospital's use of the devices did not conform to published guidelines. As moria's evolution 3 instruction manual and (b) (4) user's manual state, users should check and confirm hose connectivity and proper power levels prior to use, which apparently was not done in these cases. The physician's decision to continue with surgery and implant donor corneal tissue in both pts-despite being aware that the cut was imperfect-is also notable.
Patient Sequence No: 1, Text Type: N, H10
[21365507]
Two pts were affected -pts a and b.
Patient Sequence No: 1, Text Type: D, B5
[21553959]
Two pts were affected -pts a and b.
Patient Sequence No: 2, Text Type: D, B5
[21695298]
As a threshold matter, moria does not believe that these incidents were or are reportable, as the evolution 3 console device is not used directly on pts. Rather it is used to cut tissue from donor eyes for use in corneal transplants. If the tissue specimen is flawed in any way, the physician should not proceed with the transplant procedure. Therefore, there should be no risk to pts from an imperfect cut of donor tissue. It is unclear why the physician performed surgery with imperfect specimens in this case. That said, moria has conducted a thorough review and investigation of the medwatch reports filed by (b) (6) hospital, and hereby submits this response. This medical device report is written in response to two medwatch reports filed by (b) (6) hospital in (b) (6) (uf/importer report (b) (4)). Moria received copies of these reports on 04/03/2009. The reports state in both cases the physician decided to continue with the procedure and implant the imperfectly-cut tissue into each pt's operative eye. According to (b) (6) hospital, both pts required a second dsaek procedure to replace the implanted corneal tissue with pre-cut, eye bank tissue and are now doing well. (b) (6) hospital returned turbine #(b) (4), the turbine involved in both incidents, to moria for eval. The hospital did not, however, save and return the microkeratome blade(s) used in the incidents. Moria's inspection of the equipment reveals that there was a microscopic imperfection in the threads on the back of the turbine, which led to an insecure connection between the turbine and the turbine hose, leading to a loss of power that adversely affected the quality of the corneal cut. Further eval of a "control" turbine hose confirmed that the threading imperfection was an issue only with the particular hose used in the two incidents, and is not a problem for other hoses tested on this machine. It is possible that damage to the threading occurred either during the shipping process or in the hospital facility. To moria's knowledge, the problem with the threading on the back of the loaner turbine, and (b) (6) hospital's experiences with the device, are isolated incidents that do not present quality control issues. Moria's eval also strongly suggests that (b) (6) hospital's use of the devices did not conform to published guidelines. As moria's evolution 3 instruction manual and (b) (4) user's manual state, users should check and confirm hose connectivity and proper power levels prior to use, which apparently was not done in these cases. The physician's decision to continue with surgery and implant donor corneal tissue in both pts-despite being aware that the cut was imperfect-is also notable.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 2529598-2009-00002 |
| MDR Report Key | 1655778 |
| Report Source | 05,06 |
| Date Received | 2010-04-09 |
| Date of Report | 2009-05-01 |
| Date of Event | 2009-03-11 |
| Date Mfgr Received | 2009-03-20 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-04-14 |
| 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 Street | 1050 CROSS KEYS DR. |
| Manufacturer City | DOYLESTOWN PA 18902 |
| Manufacturer Country | US |
| Manufacturer Postal | 18902 |
| Manufacturer Phone | 2152307662 |
| Manufacturer G1 | MORIA FRANCE |
| Manufacturer Street | #45P. L.P. EVOLIC 1 |
| Manufacturer City | ANTONY CEDEX 921B2 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 921B2 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORIA EVOLUTION 3 TURBINE |
| Generic Name | NONE |
| Product Code | HMY |
| Date Received | 2010-04-09 |
| Returned To Mfg | 2009-03-20 |
| Model Number | CB |
| Catalog Number | 19303 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORIA |
| Manufacturer Address | ANTONY FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-09 |
| 2 | 0 | 1. Other | 2010-04-09 |