MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for ELANDIS manufactured by Gyrus.
[67106603]
Gyrus resectoscope neck of the scope plastic portion on the obturator broke off, was retrieved cystoscopically by the surgeon at the same time as procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067755 |
| MDR Report Key | 6313779 |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-01-30 |
| Date Added to Maude | 2017-02-09 |
| 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 |
| 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 | ELANDIS |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2017-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-07 |