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

Model Number GIF-H290Z

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

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the nozzle had foreign objects due to insufficient cleaning.Additionally, due to clogging of nozzle, air supply volume did not meet the standard value.Due to clogging of nozzle, water removal ability did not meet the standard value.Due to wear of the angle wire, bending angle in up direction did not meet the standard value.Due to wear of the angle wire, the play of up/down knob was out of the standard value.The light guide lens had a crack.The adhesive around the light guide lens was peeled.The adhesive on the bending section cover had a crack.The bending tube was deformed.The plastic distal end cover had a scratch.The connecting tube had discoloration, wrinkle, and a scratch.The customer later confirmed that they cleaned, disinfected, and sterilized the product before returning it for evaluation, and that they were not sure what the foreign material adhered to the scope¿s nozzle was.Additionally, it was confirmed there was no delay in the start of pre-cleaning, the customer flushed the nozzle with water and air, there were no abnormalities in the accessories used for reprocessing.They did not confirm whether they¿ve presoaked the endoscope in detergent solution, they¿ve wiped the nozzle with clean lint-free cloths/brushes/sponges.They flushed the air/water nozzle with detergent solution.There were no other concerns regarding the reprocessing.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 Description

An olympus marketing personnel reported on behalf of the customer that the evis lucera elite gastrointestinal videoscope had reduced angulation, the angulation knob can be operated but there was a problem.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: nozzle has foreign objects.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

Corrected fields: h6 component code (841 and 4727 should not be selected), h6 problem code (1384 should not be selected).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.Based on the results of the investigation, the root cause could not be determined.The foreign material could not be identified and the cause of the material remaining in the device could not be specified.There was no damage to the area where the foreign material was detected and it was confirmed that reprocessing was performed according to the instructions for use (ifu).The event can be detected and prevented by handling the device in accordance with the following instructions for use (ifu): gif/cf/pcf-290 series operation manual chapter 3 " preparation and inspection" shows how to detect the event.Gif/cf/pcf-290 series reprocessing manual chapter 5 "reprocessing the endoscope (and related reprocessing accessories)" shows how to prevent the event.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 18243160
• MDR Text Key: 330557880
• Report Number: 9610595-2023-18474
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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
• Device Operator: Health Professional
• Device Model Number: GIF-H290Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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