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

Model Number GIF-H180J

Device Problems Degraded (1153); Unintended Movement (3026)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis lucera elite colonovideoscope displayed an error message "white balance".The device was returned for evaluation.During the device evaluation, it was found that due to wear of the angle wire, the bending section cannot be controlled at all.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: due to wear of lock engagement lever, upward/downward knob cannot be locked securely, due to deformation of electrical connector guide pin, water tightness was lost, suction connector had corrosion due to water leakage, electrical connector had corrosion due to water leakage, electrical flexible circuit board unit had corrosion due to water leakage, electrical export, circuit board, flexible circuit board had corrosion due to water leakage, plate had corrosion due to water leakage, scope circuit board had corrosion due to water leakage, due to corrosion on electrical connector, a noise image occurs, due to a scratch on probe cover, insulation resistance value at distal end did not meet the standard value, due to wear of angle wire, bending angle in up direction did not meet the standard value, the cover of light guide bundle was damaged, probe cover had a crack, light guide lens had a chip, adhesive on bending section cover had wear, and connecting tube had a scratch.The investigation is ongoing, and 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 final investigation.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, it is likely that the bending section cannot be controlled due to wear and tear of the angle wire.The event can be prevented by following the instructions for use (ifu): operation manual_ preparation and inspection_ inspection of the bending mechanisms.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: 18223404
• MDR Text Key: 330352673
• Report Number: 9610595-2023-18205
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339110
• UDI-Public: 04953170339110
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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: 11/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2011
• 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