MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-16 for MORIA EVOLUTION II 19350 manufactured by Moria S.a..
[828737]
The patient underwent lasik surgery in 2008. Lasik surgery involves different components, including a microkeratome, which is a surgical instrument that creates a corneal flap during the surgery. Moria's lsk evolution 2 microkeratome control unit was used in the procedure on the same day. Nothing was reported to be out of the ordinary during surgery, and the control unit functioned properly during the procedure. Ten days after the surgery, the pt was having difficulty seeing out of one of her eyes. According to the physician who performed the surgery, the pt was having choriodal artery trouble and was referred to a neuro-ophthalmologist.
Patient Sequence No: 1, Text Type: D, B5
[8065273]
Dr reported the incident in 2008. Eye and surgery, the facility at which the surgery was performed, returned the microkeratome console and turbine that were used in the procedure to mfr on eight days later. The facility bought the device from mfr in1998, but moria has no records of this machine being returned for servicing before this incident. Moria examined the console and turbine. It found that the battery was not the original, and instead it was a different brand and model that was not provided by moria. The maximum voltage after charge was 12. 09 volts, instead of 13. 9 volts for a brand new battery. The battery was outside of moria's specifications. The instruction manual for the machine states that only moria batteries should be used, and the use of a different battery can result in damage of the unit or malfunctioning. The relevant pages from the instruction manual are attached. In addition, the turbine showed heavy deposits. The performance of the turbine remained in compliance with moria's technical specifications. Moria's examination also found that a broken turbine hose was screwed on the front panel connector. The silicone tubes of the vacuum circuit were a dirty-brown or yellow color, indicating possible presence of water or liquid. The vacuum level was in compliance with moria's technical specifications, but both pumps were unstable. Moria sent manhattan eye, ear and surgery a letter in 2007, reminding the co of the need to have the machine serviced. During the examination moria found stickers on the device from other companies, indicating that it may have been serviced by these companies. However, except for the replacement of the battery as explained above, moria did not find any proof of service done on the equipment. This is an isolated incident. Moria concludes that the incident was not caused by the microkeratome control unit, and could have been caused by pt-related factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2529598-2008-00001 |
| MDR Report Key | 1028547 |
| Report Source | 05,06 |
| Date Received | 2008-04-16 |
| Date of Report | 2008-04-04 |
| Date of Event | 2008-01-25 |
| Date Mfgr Received | 2008-03-04 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 2008-05-08 |
| 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 S.A. |
| Manufacturer Street | 15 RUE GEORGES BESSE |
| Manufacturer City | ANTONY 92160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORIA EVOLUTION II |
| Generic Name | EVOLUTION II CONSOLE |
| Product Code | HMY |
| Date Received | 2008-04-16 |
| Returned To Mfg | 2008-03-12 |
| Model Number | 19350 |
| Catalog Number | 19350 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005686 |
| Manufacturer | MORIA S.A. |
| Manufacturer Address | 15 RUE GEORGES BESSE ANTONY FR 92160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-16 |