MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. COLONOVIDEOSCOPE

Model Number CF-H170L

Device Problem Contamination (1120)

Patient Problems Granuloma (1876); Septic Shock (2068)

Event Date 05/29/2024

Event Type  Injury  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifiers:(b)(6).

Event Description

It was reported there was five infection cases since april after a colonoscopy with biopsy.There were no delays due to the reported event and the procedures were completed.It was later reported the five cases were for septic shock.The physician said all of the cases were bacteremia due to blood exams, there are no culture results and the symptoms started right after the procedure.One case progressed to the intensive care unit with symptoms of shivering from cold, fever of 40 degrees and low pressure.In the hospital they drew blood c-reactive protein (crp), the result was low and blood culture didn¿t show any growth; however, the doctor believes they took the blood sample after antibiotic treatment.The other four cases received intravenous ceftriaxone + metronidazole right after the procedure, when the first symptoms started.The four patient's had high blood crp and presence of granulation.The facility does manual reprocessing and they often don't do pre-cleaning in the auxiliary water channel after each procedure.The scopes were not cultured.All five patients have recovered well and are healthy.

Event Description

Additional information received: it was reported that on the day of the last infection, the autoclave had a problem.Two cases out of the five had a double exam with gastro.The facility keeps reusing single use accessories (g-flex brand) and disposable cleaning brushes (non-olympus) were reused without being disinfected.The sponges used to clean the endoscope surface are not discarded after use and not disinfected with the endoscope that was used.Concerns about reprocessing: the air/water channel cleaning adapter is not reprocessed after use.The leakage test isn't performed after each procedure.The detergent solution is not aspirated through the instrument and suction channels after brushing.The soaking time in the detergent solution is not controlled and sometimes it doesn't reach the time prescribed by the detergent manufacturer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, the device evaluation, lms final investigation, and to provide additional information received.The lm reviewed the customers provided the cds processes and confirmed the following deviation from instructions for use (ifu).- the user did not often do pre-cleaning in the auxiliary water channel after each procedure.- the user used to reuse single use forceps for biopsy (non-olympus).- non-olympus repair was performed on the device.Though the device was not sent to the repair center, an olympus technician visited the user facility and inspected the device.The following findings and recommendations were made: - stain/residue at control section (possibly detergent residue): recommended to intensify rinsing processes.- wrinkles on insertion tube: recommended to avoid excessive bends in the tube, whether during the procedure, transporting and cleaning.- bending section cover glue worn out: sign of maintenance by an unauthorized company.Recommended to send the device to the olympus repair center to redo the glue.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device was not cultured at the user facility and results of blood culture from the patients were not provided.Olympus was not able to judge the relation between the subject device and the event from the following investigation result.Therefore, the root cause could of the reported event could not be determined.The event can be detected/prevented by following the instructions for use which state: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ additional information received from technician: the following is a list of what was also found to disagree with the procedure described in olympus manuals: leak testing is not performed after each examination, the action time (soaking) of the detergent is not controlled/respected, and aspiration is not performed after brushing.Additionally, water used for irrigation through the auxiliary water channel is not sterile water and there was original olympus brush among the customer's accessories, but in regular use non-original brushes were used as well.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information received through follow up.Updated fields (d10 and h11).A technician visited the facility and identified improper reprocessing procedures and improper use of endoscopes.

• Brand Name: COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19698359
• MDR Text Key: 346452855
• Report Number: 9610595-2024-13621
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170334160
• UDI-Public: 04953170334160
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H170L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2024
• Initial Date FDA Received: 07/09/2024
• Supplement Dates Manufacturer Received: 08/29/2024; 09/26/2024
• Supplement Dates FDA Received: 08/29/2024; 10/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENDOCUFF.; NON-OLYMPUS FORCEPS.
• Patient Outcome(s): Required Intervention