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

Model Number	GIF-N180
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.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, a definitive root cause could not be determined.However, the following are the potential causes: damage to the charge coupled device (ccd) unit damage or deformation of the connector movable l-range sliding error that occurred in the zoom scope - blurred image occurred within the allowable range the event can be detected/prevented by following the instructions for use: operation manual inspection of the endoscopic system operation manual important information please read before use warnings and cautions during the device evaluation, service found a leak due to a cut and perforation in the rubber (a-rubber) in the bending section.The connecting tube had a perforation and was leaking.The adhesive on the a-rubber in the bending section was cracked.The connecting tube in the insertion section was buckling.The image guide protector had a cut.The control unit was scratched and dirty.Switch button 1 was sticky.The scope cover had a dent.The color ring in the control section was cracked.The up/down knob and scope connector were dirty.The electrical connector had corrosion.The bending angle in the up/down direction did not meet specifications due to wear of the angle wires.Due to clogging of the nozzle, the water removal ability did not meet specifications.Due to the damage to the charge coupled device (ccd) unit, the specified resolving power is not obtained.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that the subject device was leaking from the insertion tube section.There was no patient or user injury reported.The olympus field service engineer (fse) visited the customer and inspected the subject device, confirming the leak in the bending section of the insertion tube, and also observed wrinkling/buckling on the connecting tube.The device was sent to an olympus service center for further evaluation.During inspection and testing, service found the endoscopic image displayed was blurry.This report is being submitted for the malfunction [blurred image] found during the device evaluation.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16618756
• Report Number: 9610595-2023-05072
• Device Sequence Number: 15280211
• Product Code: FDS
• UDI-Device Identifier: 04953170202261
• UDI-Public: 04953170202261
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: GIF-N180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown