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

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

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 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).

• Brand Name: EVIS EXERA II 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 (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
• MDR Text Key: 315911753
• Report Number: 9610595-2023-07986
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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
• Patient Outcome(s): Other