PENTAX
Report
- Report Number
- 2518897-2024-00022
- Event Type
- Injury
- Date Received
- April 29, 2024
- Date of Event
- February 19, 2024
- Report Date
- June 21, 2024
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- EOQ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 1735 BACTERIAL INFECTION HEALTH EFFECT IMPACT CODE: 4648 INSUFFICIENT INFORMATION MEDICAL DEVICE PROBLEM CODE: 1120 CONTAMINATION COMPONENT CODE: 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE ________________ ADDITIONAL INFORMATION: SEVERAL PATIENTS HAVE BEEN INFECTED WITH PSEUDOMONAS AERUGINNOSA (PYO). BUT THE NUMBER OF PATIENTS IS UNKNOWN. THE SUSCEPTIBILITY TEST REVEALED DIFFERENT STRAINS BUT THAT THEIR GENETIC ANALYSIS COULD NOT BE CARRIED OUT DUE TO THE NON-STORAGE OF THE SAMPLES. CULTURE RESULTS PERFORMED BY THE FACILITY ON SPECIMENS TAKEN FROM THE ENDOSCOPE DETECTED 1 CFU OF BACILLUS GRAM-POSITIVE BACTERIA, BUT NO PSEUDOMONAS AERUGINOSA. THE REPROCESSING WAS SUCCESSFUL ON 2024-02-21 (TWO DAYS AFTER THE INCIDENT). THE MICROBIOLOGICAL SAMPLING ON 2024-02-21 PASSED, NO PATHOGENS HAVE BEEN DETECTED. BASED ON THE INVESTIGATION, THE CURRENT ANALYSIS DOES NOT IDENTIFY WHETHER THE SOURCE IS THE ENDOSCOPE OR THE ENVIRONMENT AS THE SOURCE. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.
CORRECTION INFORMATION B4: DATE OF THIS REPORT B5. REFER TO H11 F7: FOLLOW UP #01 F11: UPDATED DATES F13: UPDATED DATES ADDITIONAL INFORMATION D4: UNIQUE IDENTIFIER (UDI) CORRECTED F9: AGE OF DEVICE H11: EVALUATION SUMMARY EVALUATION SUMMARY THE DEVICE OF CONCERN WAS SUBMITTED TO SERVICE AT PENTAX FRANCE ON 2019-10-02 FOR THE LAST TIME AND THE DEVICE WAS FOUND IN POOR CONDITION (I.E. NON-OPERATIONAL CONDITION) AT PENTAX SERVICE ON 2024-03-04. BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE IS THE USER DETERMINED THAT THE REPROCESSING WAS INAPPROPRIATE. THE DEVICE HAS BEEN SUCCESSFULLY REPROCESSED AND REPAIRED. WE CONCLUDE THE EB15-J10 DID NOT CONTRIBUTE TO THE BACTERIAL CONTAMINATION OF ANY PATIENT EVEN THOUGH THE DEVICE WAS NOT IN OPERATIONAL CONDITION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED BY PENTAX MEDICAL MIYAGI ON 21-JUN-2017 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS, AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED AS 21-JUN-2017. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.
ON 04-APR-2024, PENTAX MEDICAL EMEA RECEIVED A NOTIFICATION SENT BY THE NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS(ANSM) REGARDING A PATIENT CONTAMINATION WHICH OCCURRED ON 19-FEB-2024. AN UNSPECIFIED RESPIRATORY INFECTION WAS NOTED IMPLICATING MICROORGANISM: PSEUDOMONAS AERUGINOSA [NMR] CONTAMINATION BY THE BRONCHOSCOPE OR THE ENVIRONMENT. THE USER SUBMITTED THE BRONCHOSCOPE FOR ANALYSIS BY PENTAX MEDICAL WITH THE SUSPICION OF CONTAMINATION. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
REFER TO H11
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 981319 | PENTAX | VIDEO BRONCHOSCOPE | EOQ | HOYA CORPORATION PENTAX TOKYO OFFICE | EB15-J10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |