MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

Model Number TJF-Q290V

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus on 05 jul 2022, a patient's blood or body fluid culture tested positive for pseudomonas aeruginosa after having an unspecified procedure in (b)(6) involving the subject device.It is unknown if the patient was symptomatic.On 13 jul 2022, the facility informed olympus an additional six (6) patients tested positive for pseudomonas aeruginosa after having an unspecified procedure in (b)(6) involving the same subject device.It is unknown if the patients were symptomatic.It is unknown if the subject device was cultured for microbial contamination.All patients have been discharged and the customer stated no serious patients and no bacteria detected although the final results have not been determined.This event includes 7 reports as follows: patient identifier (b)(6) - patient 1.Patient identifier (b)(6) - patient 2.Patient identifier (b)(6) - patient 3.Patient identifier (b)(6) - patient 4.Patient identifier (b)(6) - patient 5.Patient identifier (b)(6) - patient 6.Patient identifier (b)(6) - patient 7.This report is 1 of 7 for patient identifier (b)(6) - patient 1.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer and clarify the patients' report numbers.New information added to b5.

Event Description

The seven (7) patients with procedure dates and sampling dates have been reported as follows: (b)(6) - patient 1 - date of procedure and sampling date (b)(6) 2022.(b)(6) - patient 2 - date of procedure ((b)(6) 2022)/sampling date (b)(6) 2022.(b)(6) - patient 3 procedure date ((b)(6) 2022/sampling date (b)(6) 2022.(b)(6) - patient 4 procedure date ((b)(6) 2022)/sampling date (b)(6) 2022.(b)(6) - patient 5 procedure date ((b)(6) 2022)/sampling date (b)(6) 2022.(b)(6) - patient 6 procedure date ((b)(6) 2022)/sampling date (b)(6) 2022; aware date 05jul2022 (b)(6) - patient 7 procedure and sampling date (b)(6) 2022.This report is for (b)(6) - patient 6 procedure date (b)(6) 2022 / sampling date (b)(6) 2022.

Event Description

The facility provided additional information: the patient's procedure date was (b)(6) 2022 and the sampling date was (b)(6) 2022.The body fluid sampled was bile.Additionally, the facility plans to investigate whether other patients whose procedure was performed with the device used by the infected patient developed an infection after the procedure.The endoscope was tested and had a positive culture test.The device was used after the event.The start of pre-cleaning was delayed after the procedure.Water was not aspirated through the instrument/suction channel with a suction pump.The forceps elevator was moved to raise and lower 3 times in water during aspiration.The air/water channel was not flushed with water and air by using mh-948.The reprocessing accessories were all normal.The manual cleaning was performed within an hour after the procedure.The device passed the leak test.Product a was selected as the detergent solution but no additional information provided.The following brushed points were checked: instrument and suction channel, air/water valve/suction valve and biopsy valve.The forceps elevator was brushed, operated in the detergent solution and flushed.The distal end was flushed with maj-2319.The detergent solution was olympus endoquick.All channels were connected with tubes when the endoscope was set up into the aer/ewd.The disinfection solution used was before the expiration date and met the minimum effective concentration.The water filter was replaced within the specified period.The rinse water treatment system was without abnormality.After manual disinfection or aer process, the device is wiped with clean towel or paper, blown by compressed air and by the dry process of the aer/ewd.The endoscope is not stored in a drying cabinet.

Manufacturer Narrative

Correction: e1.This report is being supplemented to provide a correction and additional information from the customer.New information was added to the following fields: b5.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer and the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The returned device was evaluated and identified the following: bending section cover glue chipped, cracked and cloudy, insertion tube cut and boot scratched, insufficient angulation, play on angulation control knob, suction cylinder coating peeled off, scope connector and forceps elevator deformed.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to not following the correct steps in reprocessing.The following steps performed by the customer were incorrect: -occasionally the start of pre-cleaning was delayed.-not aspirating water from biopsy/suction channel with suction pump during pre-cleaning.- mh-948 was not used to supply air/liquid to the air/water channel during pre-cleaning.The instructions for use warns about inappropriate reprocessing as follows: if the instruments are not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective.Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope.

Event Description

The facility clarified the patient sampling date is the date of the lab results for the cultures.

Manufacturer Narrative

Updated field: b5 to reflect the additional information received.

Event Description

Olympus further received information that a patient became a carrier of pseudomonas aeruginosa as a result of the incident.Pseudomonas aeruginosa dna detected from patient and scope.At this time, it is unknown which patient was matched.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to h3 to include information that was inadvertently not included in previous submissions.

Manufacturer Narrative

This supplemental report is being submitted to provide further legal manufacturer¿s investigation findings based on new information that was received regarding the event.Based on the re-investigation findings, although the root cause could not be determined, it is possible that the subject device contributed to the infection in one of the patients with matching (pseudomonas aeruginosa) dna detected from the scope.However, a relationship between the subject device and the reported infections cannot be identified for the remaining six patients.As previously reported, it was determined that the user deviated from the instructions for use (ifu).This supplemental report includes a correction to g2 and h6 codes to provide information that was inadvertently not included in the previous submissions.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the facility (per capa-201237 interview).The facility reported that at the time of the event, device reprocessing was conducted according to the olympus instructions for use (ifu) manual.However, after the reported occurrence, (during an olympus demonstration) it was identified that there were deviations from the reprocessing procedures.The facility did not properly follow the reprocessing steps outlined in the olympus ifu manual.Reprocessing of the endoscope occurs with pre-cleaning simplified.Prior to cleaning with the automated endoscope reprocessors (aer) and chemicals the endoscope is washed once with joy (dishwashing detergent).Once cleaned, each channel of the endoscope is blown with endo push for about 5 seconds.Afterwards, the scopes are hung in the storage cabinet (the area that encounters the storage cabinet covered with a water-absorbing sheet which is replaced once every two weeks), and desiccant is put in the storage cabinet (replaced at least once a month).Visual and functional checks are performed during preparation for use of the device; however, damage checks are not performed, and repairs are requested when abnormalities are found or when instructions are given by doctors.It was also disclosed that during a culture test the scope came up with a positive culture, but it was determined that the outer surface of the scope encountered someone¿s hand who had touched a dirty valve.This case has already been reported to the infection control department.Additionally, it was disclosed that sometimes the staff soaks the endoscope in liquid at night and reprocesses the next morning.To prevent future occurrences, the facility has confirmed with olympus (during demonstration) that the correct reprocessing procedures are being followed.Per the facility, routine reprocessing training/education is provided to new staff members using the reprocessing materials.Based on the additional information obtained by olympus, a relationship between the subject device and the reported patient infection could not be confirmed.Therefore, there is no change to the previously reported legal manufacturer¿s investigation findings.

• Brand Name: EVIS LUCERA ELITE DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15156121
• MDR Text Key: 297143920
• Report Number: 9610595-2022-00573
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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
• Patient Outcome(s): Other