FDA Adverse Event
Malfunction
Summary report: N
COLONOVIDEOSCOPE
MDR report key: 23991455
·
Received January 7, 2026
Report
- Report Number
- 9610595-2026-01924
- Event Type
- Malfunction
- Date Received
- January 7, 2026
- Report Date
- January 7, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDF
- PMA / PMN Number
- K250432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING MAINTENANCE, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 4 KILLING CAPACITY EQUIVALENT (KBE) KLEBSIELLA PNEUMONIAE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48004 | COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | AIZU OLYMPUS CO., LTD. | CF-EZ1500DL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |