MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-05-18 for EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) 8000.COM02 N/A manufactured by Dutch Ophthalmic Research Center.
[108735191]
The surgery was completed with this device with no injury. The investigation has been started.
Patient Sequence No: 1, Text Type: N, H10
[108735192]
The head surgeon indicates, that at several occasions during surgery, he saw the blood vessels contracting and felt that the pressure is much higher than the 20mmhg displayed in the settings. He was questioning if the bottle pressure displayed is correct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00137 |
| MDR Report Key | 7526214 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-05-18 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-08-16 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2018-05-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS FRYER |
| Manufacturer Street | SCHEIJDELVEQEG 2 BLDG 1 |
| Manufacturer City | ZUILAND, NETHERLANDS NH 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal | 3214 VN |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, NETHERLANDS 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214 VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) |
| Generic Name | PHACOEMULSIFICATION/VITRECTOMY SYSTEM |
| Product Code | MLZ |
| Date Received | 2018-05-18 |
| Model Number | 8000.COM02 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPHTHALMIC RESEARCH CENTER |
| Manufacturer Address | SCHEIJDELVEWEG 2 3214 VN ZUIDLAND, 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-18 |