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

Model Number	GIF-XP150N
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 that due to damage on the charge coupled device (ccd) unit, the image had shadows, and the specified resolving power was not obtained.Additionally, there was a leak due to damage to the air/water tube.The objective lens was cracked.The adhesive on the bending cover (a-rubber) was cracked.The connecting tube was wrinkled.Switch 2 had a cut.The universal cord was deformed and scratched.Due to wear of the angle wires, the bending angles in the up/down and left/right directions did not meet the specifications.Due to wear of the angle wires, the up/down knob and left/right knob did not meet the specifications.Due to corrosion, switch 1 did not work.Due to the nozzle missing, the amount of water contact did not meet the standard value.Due to damage on the air/water tube, water removal ability did not meet the standard value.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 subject device was received at an olympus service center for evaluation with no complaint reported.There was no patient or user injury reported.During inspection and testing, service found the endoscopic image was blurry.This report is being submitted for the malfunction [blurred image] found during the device evaluation.

• Brand Name: 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: 16640170
• Report Number: 9610595-2023-05236
• Device Sequence Number: 14763610
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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-XP150N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2010
• 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