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

Model Number	GIF-XP180N
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.The device met all specifications at the time of shipment.It has been over 11 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation.Although, a conclusive root cause could not be determined.It is likely, that a blurry image was displayed due to the following: the entire image was blurred due to damage to the ccd unit.The entire image was blurred due to sliding error of movable l-range that occurred in the zoom scope.Blurring the entire image occurred within the allowable range.The entire image was blurred due to damage or deformation of the connector.Testing and inspection confirmed the customer¿s complaint, due to wear of angle wire, bending angle in up/down and right/left direction does not meet the standard value.The adhesive on the bending section cover had a crack.In addition, testing and inspection found the following: due to damage on the channel tube, water tightness is lost.The connecting tube had a wrinkle due to chemical stress.Due to physical stress the scope cover and grip had a scratch, and due to handling the forceps channel and scope cylinder were shaved.Due to handling, the control unit and switch box had a scratch.Due to humidity, the universal cord was sticky.Due to handling, the following were scratched: light/guide cover glass, the scope connector, plug unit, scope connector case.Due to wear of angle wire, the play of the up/down and left/right knob is out of the standard value.Due to a dent on the channel tube the cleaning brush cannot be inserted smoothly.Due to deformation of nozzle, water removal ability does not meet the standard value.Due to breakage of light/guide bundle, illumination is uneven 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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus, that during preparation for use they discovered that the bending section cover was deformed, and the degree of angulation was abnormal.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing, the following was found: the endoscopic image was blurred.This report is being submitted for the malfunction found during evaluation (the endoscopic image was blurred).

• 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: 16592020
• Report Number: 9610595-2023-04840
• Device Sequence Number: 2907056
• Product Code: FDS
• UDI-Device Identifier: 04953170307515
• UDI-Public: 04953170307515
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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-XP180N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2012
• 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