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

Model Number GIF-H190

Device Problems Device Reprocessing Problem (1091); Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus received information that this gastrointestinal videoscope had processing defect and confirmed enterobacter cloacae contamination.The customer did viral risk analysis for patients having undergone endoscopy between the last conform sample and the date of sequestration.As reported, three patients have undergone endoscopy with this non-conform device and patient recall in progress.The customer's opinion of the cause of the issue are processing fault and the age of the device.Additional information has been requested.Three (3) reports are needed for this event with patient identifiers: (b)(6)- 1 of 3 patients, (b)(6)- 2 of 3 patients, (b)(6)- 3 of 3 patients.This report is for (b)(6).

Manufacturer Narrative

The customer provided the cleaning, disinfection, and sterilization process stating that precleaning was performed immediately after the procedure.Air/water was aspirated through the instrument/suction channel with a suction pump.The device passed the leak test.During manual cleaning, the detergent used was anuostme3.The instrument/suction channel, suction cylinder and instrument channel port were brushed.The automated endoscope reprocessor (aer) used was wassenburg with endohigh detergent and endohigh paa disinfectant.All channels connected with tubes when the endoscope was setting up into the aer.The water quality of the rinse water was not controlled.The device was dried by wiping with sterile paper and stored in drying cabinet.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus further received information that the 3 patients at risk received a registered letter and a medical prescription.The device revealed contamination after it had been repaired.No other information provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned, a culture test and a device inspection could not be performed by olympus.A relationship between the subject device and the suspected patient infection could not be identified.Although the customer provided positive culture test results performed by a third-party laboratory, olympus confirmed that there were no obvious deviations from the reprocessing steps outlined in the instructions for use (ifu) based on the information provided.Finally, since the date of the procedures for the three patients involved is unknown, the root cause could not be determined.The event can be detected/prevented by following the ifu which state: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ this supplemental report includes information added to h4.Also, a correction has been made to b6 to provide information that was not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 17224438
• MDR Text Key: 318082724
• Report Number: 9610595-2023-09482
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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: WASSENBURG.
• Patient Outcome(s): Other