MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for EXTENDED FLEXTIP CANNULA 3298 manufactured by Medone Surgical, Inc..
[121916767]
Patient underwent a 25-gauge trans pars plana vitrectomy with endolaser and air fluid gas exchange to the left eye. A 25-gauge extended flex tip cannula and the small clear flexible tip became detached from the device and was lost within the eye. The surgeon was unable to retrieve this item.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080113 |
| MDR Report Key | 7910315 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-09-18 |
| Date Added to Maude | 2018-09-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EXTENDED FLEXTIP CANNULA |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2018-09-25 |
| Model Number | 3298 |
| Lot Number | A1812 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDONE SURGICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |