MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number	TJF-Q180V
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D1.The customer was unable to provide the model and serial number for the scope involved.A representative product code and legal manufacturer was selected based on related complaints.The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A user facility reported to olympus that there was a concern for infection on the repair request.Upon follow up, it was stated that 11 patient's at the facility were infected with pseudomonas aeruginosa 4 mrgn vim positive.The facility did not have any specifics regarding the patient's and when the procedures occurred, or any other infection details.It was only stated that all 11 patients had procedures between (b)(6)2022 and (b)(6) 2022 with the last detection of the micro-organism in march 2023.It was stated that it became clear to the facility in (b)(6) 2023 that the scope was the cause for infection.The entire cleaning process had been reviewed by local regulatory authorities, including the cleaning machines, and it was found that the reprocessing was adequate.The following outcomes were reported: three of the 11 patients have since died.The facility has clearly communicated that the infection was not the cause of death, but rather, their pre-existing conditions.Eight of the 11 patients are "doing well." one of these eight patients was placed on the liver transplant list after the infection.The facility refused to clarify if it was directly due to the infection or not.As there are 11 total patients, the patient identifiers are as follows: (b)(6).This mdr is for patient identifier (b)(6).
Additional Manufacturer Narrative
Additional information obtained suggested the device used for this patient was the same device as the other 10 patients involved.Thus, device information was updated to the known affected serial number.The device was returned under related patient identifier (b)(6).The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, foreign material was discovered in the forceps elevator.The customer's originally reported issue of defective instrument channel was not confirmed.The following additional findings were also noted: image guide protector cut, connecting tube buckled, objective lens adhesive worn, light guide lens discolored, and left arm corroded.Additional information was obtained regarding microorganism testing performed at an independent lab.The scope was sampled twice - once in the forceps raiser, and once in the biopsy/suction channel.The samples were tested for e coli/other enterobacteriaceae, enterococci, p.Aeruginosa/other non-fermenter, staph aureus, greening streptococci, and germ differentiation.Both samples tested negative for all microorganisms.This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and the device history record (dhr) review, as well as supplemental information in b5, d1, d2, d3, d10, g4, h4, and h6.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause could not be conclusively identified.The patient strain was never identified in the endoscope(s) itself and, unfortunately, no scope was tested during the time of the event.A clonal identity of at least 10 available patient samples was confirmed by an external lab.The endoscope investigated - especially parts coming in contact with patients - did show signs of wear & tear and even foreign material was detected at the elevator forceps which might have prevented successful reprocessing and might follow in contamination/patient infection.So, the fact that olympus found foreign material indicates that we cannot say rule it out completely.We cannot say that it is 100% sure that the foreign material resulted in positive cultures.Health authorities inspected the cleaning machines, as well as the entire cleaning process at the user facility and concluded that reprocessing was adequately conducted.We have no information to judge that the defect was misuse by the user, and ultimately, no root cause could be applied.
Event or Problem Description
It was additionally reported that the first infection was detected on (b)(6) 2022 via molecular typing.There were no symptoms detected on that first/index patient.It was clarified that the infected patients were in-patient at the time.Only a small proportion of patients had actual infections but all 10 samples were identically infected with pseudomonas aueroginosa 4 mrgn vim+ (clonal identity of the isolate).Only one patient (unidentified which patient this was) had signs of cholangitis, but most patients had no signs of infection.It was assumed by the facility that the first patient was a carrier of the strain, but this cannot be proven as their isolate was no longer available for molecular typing.Antibiotic treatment was provided to the patients.From (b)(6) 2022 through (b)(6) 2022, the endscope was reprocessed and used 44 times.The scope was sent for repairs and returned on (b)(6) 2022.From (b)(6) 2022 to (b)(6) 2023, the endscope was reprocessed and used 80 times.After returning from repair, no further infections have occurred.Lastly, it was stated that there was a total of 4 other cases of pseudomonas aueroginosa 4 mrgn vim+ detected in the hospital that did not have scoping procedures through out 2022 until the end of march 2023.However, the strains were not identical to each other, nor to the outbreak strain per molecular typing.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• 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: 16996540
• Report Number: 9610595-2023-07986
• Device Sequence Number: 18987676
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown