MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for EDGEPLUS VALVED ENTRY SYSTEM 8065751586 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[95382091]
This report was originally filed as 1644019-2017-00805. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95382092]
A healthcare professional reported that one trocar was immediately blunt after the cap was removed; it was not possible to make a port with it. Event timing, procedure impact and patient outcome are unknown. Additional information was received. The blunt trocar was noted during a pars plana vitrectomy procedure. It was reported that it looked like it had fallen on its tip. It did not come into contact with the patient and there were no negative consequences for the patient. The trocar was replaced, but the same issue was presented. A third trocar was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2017-04532 |
| MDR Report Key | 7125621 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-11-22 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-12-18 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDGEPLUS VALVED ENTRY SYSTEM |
| Generic Name | CANNULA, TROCAR, OPHTHALMIC |
| Product Code | NGY |
| Date Received | 2017-12-18 |
| Model Number | NA |
| Catalog Number | 8065751586 |
| Lot Number | 16040302X |
| ID Number | NA |
| Device Expiration Date | 2018-09-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-18 |