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

Model Number GIF-H180J

Device Problems Pressure Problem (3012); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported no insufflation on the evis exera ii gastrointestinal videoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: the nozzle of the insufflation channel was clogged by dark rubbery material.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the reported malfunction was confirmed.A full technical evaluation was completed, and the results showed that there was air/water flow issues.The nozzle of the insufflation channel was clogged by dark rubbery material likely due to insufficient cleaning.Additionally, the charged coupled device (ccd) glue was worn-out.The connecting tube was buckled.The bending angulation was out of standard values.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 is being supplemented to provide additional information based on the legal manufacturer's 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 nine years since the subject device was manufactured.Based on the results of the investigation, the root cause of the reportable malfunction could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: ifu states the detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection ifu states the preventative measures in evis exera ii gif/cf/pcf type 180 series reprocessing manual 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: 18564592
• MDR Text Key: 333490674
• Report Number: 9610595-2024-01458
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170307539
• UDI-Public: 04953170307539
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051645
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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