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 23G 8300.23G02 manufactured by D.o.r.c International.
[90406289]
This incident has occurred during surgery, formation of bubbles during surgery might lead to patient harm, hence this complaint is concluded as reportable. This is reportable because of the bubble issue while using vitrectome. 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. Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017. All available information has been disclosed.
Patient Sequence No: 1, Text Type: N, H10
[90406290]
A hospital from (b)(6) has reported the following problem that occurred the unit didn`t keep the cartridge. It throws out bubbles with the vitrectome and infusion line. No sample is available for an evaluation. There is no information of patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2017-00023 |
| MDR Report Key | 6950566 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-14 |
| Date of Report | 2014-04-22 |
| Date of Event | 2014-04-22 |
| Date Mfgr Received | 2014-04-22 |
| 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 23G |
| Generic Name | EVA VITRECTOMY PACK VGPC INPUT 23G |
| Product Code | MLZ |
| Date Received | 2017-10-14 |
| Catalog Number | 8300.23G02 |
| Lot Number | 2000362025 |
| 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 |