FDA Adverse Event
Death
Summary report: N
EVIS EXERA III DUODENOVIDEOSCOPE
MDR report key: 20297658
·
Received September 24, 2024
Report
- Report Number
- 2429304-2024-0000419
- Event Type
- Death
- Date Received
- September 24, 2024
- Report Date
- September 24, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- UDI-DI
- 04953170405563
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED IN A SOCIAL MEDIA POST THAT A PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), PROCEDURE WITH AN OLYMPUS SCOPE BELIEVED TO BE JF AT A US FACILITY PASSED AWAY. THE POST STATED AN UNSTERILIZED OLYMPUS SCOPE WAS USED THAT WAS RECALLED. FURTHER FOLLOW-UP HAS BEEN CONDUCTED; HOWEVER, NO INFORMATION IS AVAILABLE REGARDING PATIENT DEATH AT THIS TIME. SINCE THE SOCIAL MEDIA POST MENTIONED AN ERCP SCOPE WAS USED, HENCE A REPRESENTATIVE DEVICE EVIS EXERA III DUODENO VIDEOSCOPE, MODEL -TJF-Q190V REGISTERED AND SOLD IN THE UNITED STATES HAS BEEN SELECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1292329 | EVIS EXERA III DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q190V | 04953170405563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death| H |