MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-19 for OES URETERO-RENO FIBERSCOPE URF-P5 manufactured by Olympus Medical Systems Corp..
[185601162]
The subject device was not been returned to olympus medical systems corp (omsc). The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[185601163]
Olympus medical systems corp. (omsc) received a literature titled? Clinical study of pcnl and urs for kidney stones with a major axis of 20 mm or more?. The literature reported the result of 31 cases of ureterorenoscopy (urs) between january 2013 and december 2017. There was a possibility that urs was performed using the urf-p5. In this literature, it was reported adverse events as follows: ureteral injury: 2 cases. Fever: 4 cases. Fever (septic shock): 1 case. Based on the available information, a direct relationship between the subject device and the reported adverse events could not be determined. Omsc is submitting seven mdrs according to the number of the adverse events. This is 1 of 7 reports. (1 of 2 ureteral injury cases).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01413 |
| MDR Report Key | 9725604 |
| Report Source | LITERATURE |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OES URETERO-RENO FIBERSCOPE |
| Generic Name | URETERO-RENO FIBERSCOPE |
| Product Code | FGB |
| Date Received | 2020-02-19 |
| Model Number | URF-P5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |