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

Model Number GIF-H190

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

Customer reported an air/water (a/w) or aspiration problem.The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.Device evaluation , service repair inspection found nozzle clogging, foreign material cannot be removed even if correct reprocess is performed due to buckling of each channel or nozzle.This report is being submitted for clogging of nozzle, foreign material stuck due to buckling of the channel (handling issue, problems related to reprocessing ).

Manufacturer Narrative

The subject device inspection and evaluation has started.The device evaluation final report and completion report has not yet been received.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation (updated d9 with date returned), and to add h4.The device was returned to olympus for inspection, and the customer's complaint was confirmed.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.It was confirmed that the air/water nozzle was clogged with a solid foreign material, however, the specific material could not be identified.Although the nozzle was found to be deformed the cause for the clog could not be conclusively specified.Attempts were made to obtian additional information but the only response was that the cusotmer follows the instructions for use (ifu).The event can be prevented by following the instructions for use (ifu) which state: "if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope." "to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the aw channel cleaning adapter (mh-948) after each patient procedure." "nothing other than sterile water should be used for air/water feeding.No additives should be put into the sterile water.Non-sterile water may cause patient cross-contamination and/or infection." "all cloths used in reprocessing are recommended to be lint-free.Lint or cloth fibers shed into reprocessing fluids may be injected into the endoscope channels.There is the potential for lint or cloth fibers to lodge in channels or become trapped in the air/water nozzle.If gauze is used to reprocess the endoscope, ensure that fibers do not get caught on or remain trapped by protruding components like the air/water nozzle." in addition, the following non-reportable malfunctions were found during the device evaluation; the glue on the bending section cover (a-rubber) had seperated and there were air/water flow issues from the air/water flow system.Furthermore, no water leaks were observed during the air leak inspection.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 15879975
• MDR Text Key: 307797269
• Report Number: 9610595-2022-04617
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2017
• 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