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
Event or Problem Description
The customer reported that, during reprocessing, the subject device had leakage from the bending section cover.The subject device was sent to olympus for evaluation.During inspection and testing, the image was blurred.This report is being submitted for the malfunction found during evaluation (blurred image).There was no harm or user injury reported due to the event.
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.During inspection and testing, the image was blurred.A review of the device history record found no deviations that could have caused or contributed to the blurred image.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the following are the probable causes: the entire image was blurred due to damage to the charge-coupled device unit, the entire image was blurred due to a sliding error of movable length range that occurred in the zoom scope, blurring of the entire image occurred within the allowable range, or the entire image was blurred due to damage or deformation of the connector.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: operation manual: inspection of the endoscopic system.Operation manual: important information ¿ please read before use: warnings and cautions.Olympus will continue to monitor field performance for this device.The report of leakage from the bending section cover was confirmed.The leak was due to a cut on the bending section cover.In addition, water removal ability did not meet the standard due to clogging of the nozzle, angulation in the down direction did not meet the standard value due to wear of the angle wire, there was a gap in the adhesive on the bending section cover, the bending section cover was worn due to excessive stress, the objective lens was chipped due to a shock caused by dropping and knocking the device to a hard surface, and there were white dots in the image due to damage on the charge coupled device.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• 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: 16600815
• Report Number: 9610595-2023-04929
• Device Sequence Number: 6164918
• Product Code: FDS
• UDI-Device Identifier: 04953170307478
• UDI-Public: 04953170307478
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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: 03/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2017
• 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