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

Model Number GIF-H180

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during reprocessing of the evis exera ii gastrointestinal videoscope, the scope had blocked channel and could not be clean/ disinfected fully.There was no patient involvement reported with this event.

Manufacturer Narrative

Investigators reported that the scope was received with a biohazard sticker and the scope was not inspected, and completely refurbished.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report has been submitted to provide additional information from the customer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

Additional information was received from the customer that the scope was fine throughout the procedure and the scope was brushed and cleaned appropriately without any issues.The evotech (oer) reprocessor/washer did not pass the scope and exhibited a clogging error.It was reported that the scope was not used with the foreign material in the endoscope.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device underwent repair in the past one year.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.The suggested event is detectable and preventable by handling the device in accordance with the following ifu.-evis exera ii gif/cf/pcf type 180 series operation manual includes the detection way in chapter 3 preparation and inspection.-evis exera ii gif/cf/pcf type 180 series reprocessing manual includes the preventive measures in chapter 5 reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16850925
• MDR Text Key: 314465338
• Report Number: 9610595-2023-06963
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339776
• UDI-Public: 04953170339776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/02/2023; 05/24/2023
• Supplement Dates FDA Received: 05/08/2023; 06/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2008
• 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