FDA Adverse Event
Malfunction
Summary report: N
URETERO-RENO FIBERSCOPE
MDR report key: 8774556
·
Received July 10, 2019
Report
- Report Number
- 8010047-2019-02473
- Event Type
- Malfunction
- Date Received
- July 10, 2019
- Date of Event
- June 11, 2019
- Report Date
- July 9, 2019
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FGB
- UDI-DI
- 04953170340833
- PMA / PMN Number
- K172298
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem · 1
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE IMAGE OF THE SUBJECT DEVICE BECAME BLACK DOT DURING A RETROGRADE INTRARENAL SURGERY (RIRS). THE PATIENT WAS DISCHARGED 2 DAYS AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568069 | URETERO-RENO FIBERSCOPE | URETERO-RENO FIBERSCOPE | FGB | OLYMPUS MEDICAL SYSTEMS CORP. | URF-P6R | 04953170340833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization |