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

Model Number	GIF-XTQ160
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed, the device evaluation found that the biopsy channel was checked with a borescope and no foreign body was found, the channel was suctioned with air / water and nothing came out and no restrictions were felt.The cleaning, disinfection, and sterilization (cds) was not performed by the customer before the device was returned to olympus for repair.Additional findings include the following: the plastic distal end cover had dents / scratches, the bending section cover adhesive had a crack / was catching cotton / had discoloration, the objective lens cement was peeling, the light guide lens cement was peeling, the image had a halo due to the objective lens adhesive peeling, the light guide tube had superficial scratches / buckles (which did not affect the functionality), the scope connector had a customer label, the angulation in the up direction was low, the up / down knob was loose, and the right / left / up / down control knob movements were loose.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the evis exera gastrointestinal videoscope had a foreign body stuck inside of the scope.The issue was found during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) spyglass procedure, the procedure was completed with a similar device, and without delay.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the suggested event ¿foreign material clogged in the device¿ was not confirmed.It could not be specified what the foreign material was and the root cause of the remaining foreign material.There was deviation from instructions for use (ifu) in reprocessing steps for the area where the foreign material remained.No physical damage to the device was confirmed where the foreign material remained.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The suggested event is detectable/preventable by handling the device in accordance with the following ifu.Ifu states the detection method in evis exera gif type xtq160 operation manual chapter 3 preparation and inspection.Ifu states the preventative measures in evis exera gif type xtq160 reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 17868768
• Report Number: 9610595-2023-14576
• Device Sequence Number: 7601552
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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-XTQ160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2017
• 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