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

Model Number TJF-Q190V

Device Problem Microbial Contamination of Device (2303)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The device will not be returned to olympus for evaluation.As part of the investigation into this report, an olympus endoscopy support specialist (ess) has been dispatched on-site to assess the reprocessing practices at the user facility.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that during routine microbiological testing, the evis exera iii duodenovideoscope tested positive for an unexpected contamination.The testing was performed after a therapeutic endoscopic retrograde cholangiopancreatography procedure.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2024-00017.This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: additional information in evaluation tab update to b1, b2, b5, g2, h1, h4, h6 and h10 an correction to h6.Additional information revealed that the faclity use sterile water and inject it into the instrument channel of the scope.The water is collected in a container at the distal tip of the scope.They use a sterile swab w iping the distal tip of the scope as well as the elevator.The swab is then placed in the same sample of water from the instrument channel.Only one sample is sent off for evaluation.Due to the asset listing error, the customer has not been able to try anything with the scope.It is currently quarantined and not in use.The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information from the olympus employee reported that upon follow-up at the site and discussing the positive culture report with the customer, it was discovered the facility had two potential patients post procedure infections.Both instances the patient had an ercp- endoscopic retrograde cholangiopancreatography procedure before the infection and a culture positive scope was used in the procedure.The customer has not disclosed the date the scopes were cultured, and the type/growth of microbiological organism tested.The facility is reported to be inquiring further details from the infection prevention control.2 similar occurrences have been reported by the customer for patients having post-procedure infections at their facility with the patient identifiers: patient identifier # (b)(6) evis exera iii duodenovideoscope tjf-q190v, sn 2124301 (this report).Patient identifier # (b)(6) evis exera iii duodenovideoscope tjf-q190v sn -unk.

• Brand Name: EVIS EXERA III 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: 18440392
• MDR Text Key: 331884861
• Report Number: 9610595-2024-00182
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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