MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5 manufactured by Olympus Corporation Of The Americas Headquarters.
[108982500]
Olympus flexible cystoscope used in operating room procedure (second stage buccal urethroplasty w/suprapubic catheter placement). Scope was intact at start of procedure but when removed after use, about 3 cm of its covering was missing, exposing metal mesh. Field was searched and all pieces were accounted for. No known injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077343 |
| MDR Report Key | 7533527 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-04-06 |
| Date Added to Maude | 2018-05-22 |
| 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 | 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 | 3 |
| Brand Name | OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5 |
| Generic Name | OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5 |
| Product Code | FBO |
| Date Received | 2018-05-21 |
| Returned To Mfg | 2018-05-17 |
| Model Number | CYF-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF THE AMERICAS HEADQUARTERS |
| Manufacturer Address | 3500 CORPORATE PKWY CENTER VALLEY PA 180340610 US 180340610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |