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

Model Number GIF-H260

Device Problems Mechanical Problem (1384); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis lucera gastrointestinal videoscope displayed a low quality image with lines on screen.The issue was found during maintenance.There was no patient involvement.Subsequently the device was returned to olympus and evaluated.It was discovered that there was a small black disk approximately 5mm wide that fell out when the side cover was removed during repair.This medwatch report is being submitted to capture this reportable malfunction which was identified during the evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation.The customers¿ allegation of image lines on the screen causing low quality was not confirmed.The cause of the disc was likely from a previous repair or manufacturer.The following events were noted in the evaluation and are as follows: (a.) light cover glasses adhesive was worn, (b.) optical cover glass adhesive was worn, (c.) the distal end adhesive was worn, (d.) the control body identity badge was damaged, (e.) the switch condition was damaged, (f.) the up/down/right angle was out of specification, (g.) the up/down left/right angle was out of play, (h.) and the lines on the screen was low quality.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.

Manufacturer Narrative

This report is being supplemented 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.It has been nearly 14 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the plastic disk could not be determined at this time.However, it is likely the plastic disk accidentally entered the subject device during the previous repair or the subject device was disassembled by the user and/or a third-party which caused the plastic disk to enter the device.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: 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: 17180960
• MDR Text Key: 318223739
• Report Number: 9610595-2023-09157
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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
• Device Operator: Health Professional
• Device Model Number: GIF-H260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1