MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for ALCON UNK manufactured by Alcon.
[93442400]
A 27 gauge soft tip cannula, 0. 8 mm was requested for case. Dr placed trocars into eye and inserted soft tip cannula. Operation commenced and soft tip was removed from eye. At that time it was noticed that tip was missing but could not be located. Another soft tip was retrieved and introduced through trocar. At this time the tip to the cannula was seen floating inside the eye. It is thought that the tip loose and lodged inside the trocar. Introduction of the second soft tip pushed the loose tip into the eye. A 27 gauge max grip force was used to remove the loose cannula tip from the eye. There was no impact to pt other than delay of case. Diagnosis or reason for use: pars plana vitrectomy endolaser, cryo, air-fluid exchange. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073647 |
| MDR Report Key | 7071501 |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-11-16 |
| Date Added to Maude | 2017-11-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALCON |
| Generic Name | 27 GAUGE SOFT TIP CANNULA, 0.8 MM |
| Product Code | NGY |
| Date Received | 2017-11-30 |
| Returned To Mfg | 2017-11-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 998255M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-30 |