MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for RESECTOSCOPE manufactured by Gyrus Acmi, Inc. / Olympus Surgical Technologies America.
[142177354]
The ceramic tip of the resectoscope broke off. Dr was performing an elective turbt with the resectoscope. It was noted that the tip of the resectoscope was broken off during the procedure. The collection bag at the end of the bed was searched and the piece was found. The piece completed the scope. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085877 |
| MDR Report Key | 8518546 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-04-08 |
| Date Added to Maude | 2019-04-16 |
| 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 |
| 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 | 3 |
| Brand Name | RESECTOSCOPE |
| Generic Name | RESECTOSCOPE |
| Product Code | FJL |
| Date Received | 2019-04-15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. / OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
| Brand Name | RESECTOSCOPE |
| Generic Name | RESECTOSCOPE |
| Product Code | FJL |
| Date Received | 2019-04-15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. / OLYMPUS MEDICAL SURGICAL TECHNOLOGIES AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-15 |