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 2018-05-22 for DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (27 GAUGE / 0.4 MM) 1272.EDPP4 manufactured by Dutch Opthalmic Research Center Bv.
[108906754]
The investigation showed that there are gray particles on the inserter. The cannula and the closure valve where not return for investigation. The investigation could not reveal the root cause of this complaint. During the retrospective review the risk is foreign matter or foreign body reaction, hence concluded as reportable. (b)(4). All available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[108906755]
A facility has reported that they found a gray particle on a trocar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00143 |
| MDR Report Key | 7533018 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-22 |
| Date of Report | 2015-12-29 |
| Date of Event | 2015-12-29 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2018-05-22 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 BLDG 1 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (27 GAUGE / 0.4 MM) |
| Generic Name | DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (27 GAUGE / 0.4 MM) |
| Product Code | NGY |
| Date Received | 2018-05-22 |
| Catalog Number | 1272.EDPP4 |
| Lot Number | 2000368387 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, 3214VN NL 3214VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |