COLONOVIDEOSCOPE
Report
- Report Number
- 9610595-2025-20738
- Event Type
- Malfunction
- Date Received
- September 12, 2025
- Date of Event
- July 30, 2025
- Report Date
- January 21, 2026
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDF
- PMA / PMN Number
- K222584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 501
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
UPDATED INFORMATION WAS ADDED TO H2, H3, H6, AND H11. CORRECTED FIELDS: G2 ADDED HEALTH PROFESSIONAL. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE THIRD-PARTY TESTING RESULTS, THE DEVICE EVALUATION, AND THE COMPLAINT INVESTIGATION. DESPITE GOOD FAITH ATTEMPTS, THE USER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WERE NOT SHARED. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: ALL CHANNELS, CFU: 43 CFU, BACTERIAL IDENTIFICATION: CORYNEBACTERIUM SPECIES, STAPHYLOCOCCUS HAEMOLYTICUS, CELLULOSIMICROBIUM. SP: SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: OPERATOR CHANNEL, CFU: 9 CFU, BACTERIAL IDENTIFICATION: KOCURIA PALUSTRIS. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: OPERATOR SUCTION CHANNEL, CFU: >80 CFU, BACTERIAL IDENTIFICATION: AUTRES GRAM-POSITIVE BACILLI AND MESOPHILIC BACILLUS SPP. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: AIR WATER CHANNEL, CFU: 11 CFU, BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE; KOCURIA SP. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: AIR WATER JET CHANNEL, CFU: 1 CFU, BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: OPERATOR CHANNEL, CFU: 2 CFU, BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: OPERATOR SUCTION CHANNEL, CFU: 2 CFU, BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: AIR WATER CHANNEL, CFU: 3 CFU, BACTERIAL IDENTIFICATION: KOCURIA RHIZOPHILA. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: OPERATOR SUCTION CHANNEL, CFU: 2 CFU, BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: OPERATOR CHANNEL, CFU: 1 CFU, BACTERIAL IDENTIFICATION: MICROCOCCACEAE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE IFU BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR MORE THAN 100 COLONY FORMING UNITS (CFU) OF PSEUDOMONAS ON (B)(6) 2025 AND (B)(6) 2025. ALL CHANNELS WERE SAMPLED. 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.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
IT WAS REPORTED THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE OCCURRED DURING A LAB/DEMONSTRATION WITH NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2594680 | COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | AIZU OLYMPUS CO., LTD. | CF-HQ1100DI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |