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

Model Number	GIF-XP290N
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, while using the video scope, angulation was reduced.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: there was a foreign object inside the nozzle.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed for angulation being reduced due to a foreign object inside the nozzle.Additional evaluation found due to wear of angle wire, play of up and down knob and bending angle in up direction does not meet the standard value.Due to clogging of nozzle, water supply volume and water removal ability does not meet the standard value.The connecting tube has a dent, scratch, and is discolored.The bending section cover has; a scratch, discoloration, and adhesive chipped.Due to a dent on bending tube, bending angle in up direction exceeds the standard value.Due to deformation of bending tube, connection between bending section and connecting tube is not secured.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to correct information that was provided in the initial medwatch report and 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.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the foreign material could not be identified.Hence, a conclusive root cause of the foreign material remained in the device could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: - ifu states that detection method in gif/cf/pcf-290 series operation manual chapter 3 preparation and inspection.- ifu states that preventive measure in gif/cf/pcf-290 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Attempts were made to obtain additional information regarding the customer's cleaning, disinfection, and sterilization processes, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18197250
• Report Number: 9610595-2023-18004
• Device Sequence Number: 6403473
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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-XP290N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 11/23/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2016
• 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