MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-14 for EVA VITRECTOMY PACK VGPC INPUT 25G 8300.25G02 manufactured by D.o.r.c International.
[90400491]
We have extensively tested vitrectoom. Our r & d department has made a change. As was already indicated in the snf, the new vitrectoom will soon be available. Our csc department can tell when the new series is available. Bubbles can lead to a patient harm, hence reportable. Performance varies in- and out-of-specification. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer. (b)(4). All available information has been disclosed.
Patient Sequence No: 1, Text Type: N, H10
[90400492]
Today we faced a new and very serious issue and we are trying to understand the reasons for it. It was noticed bubbles from the aspiration port of the cutter at high cut rate-shaving mode. Information reasonably suggests that this incident occurred during surgery. No information of patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2017-00024 |
| MDR Report Key | 6950567 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-14 |
| Date of Report | 2014-05-20 |
| Date of Event | 2014-05-20 |
| Date Added to Maude | 2017-10-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LAURA SMITH |
| Manufacturer Street | 10 CONTINENTAL DR |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037538824 |
| Manufacturer G1 | D.O.R.C INTERNATIONAL |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, 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 VITRECTOMY PACK VGPC INPUT 25G |
| Generic Name | EVA VITRECTOMY PACK VGPC INPUT 25G |
| Product Code | MLZ |
| Date Received | 2017-10-14 |
| Catalog Number | 8300.25G02 |
| Lot Number | 2000358476 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C INTERNATIONAL |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-14 |