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

Model Number	GIF-H260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported poor air supply from the evis lucera gastrointestinal videoscope.There were no reports of patient harm.The device was returned for evaluation.Upon inspection and testing, the nozzle was clogged with foreign material.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the device was manufactured.The device evaluation found the water supply volume and the water removal ability did not meet the standard values due to the clogging of the nozzle.The bending section cover had cracked adhesive, the electrical connector was discolored due to water leakage, switch 1 and switch 3 had scratches, switch 4 had wear, the universal cord protector had a scratch on the s-connector side, the objective lens had a crack, the connecting tube had a scratch, and a deformed insertion tube were discovered.During the device evaluation, the foreign matter could not be identified.Based on the results of the investigation, the foreign material found in the nozzle may have been the result of insufficient cleaning, however, a definitive root cause could not be determined.This issue is addressed in the instructions for use (ifu): ¿chapter 3 preparation and inspection, 3.2 inspection of the endoscope, and 3.6 inspection of the endoscopic system¿ describes the following warning.Inspection of the endoscope 9.Inspect the air / water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.Inspection of the objective lens cleaning function 1.While covering the spray valve hole with your finger, depress the valve all the way (till the 2nd step) and confirm that water flow is observed in the entire endoscopic image.2.While keeping the spray valve hole covered, depress the valve till the first stop position (till the 1st step) and confirm that emission of water spray is observed in the entire endoscopic image.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS LUCERA 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: 17266688
• Report Number: 9610595-2023-09759
• Device Sequence Number: 8061557
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011151
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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-H260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2013
• 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