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 subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem, of air/water flow issues was confirmed.The device evaluation found that the nozzle was clogged with foreign objects from insufficient cleaning.The device evaluation also found that the objective lens, light guide lens and bending section cover had adhesion cloudiness and the bending section cover adhesion was chipped.It was also found that plastic distal end cover was crushed and the light guide coil was wrinkled.Scratches were found on multiple components.Due to the nature of the reportable event (foreign material found in the nozzle), follow up regarding the cleaning sterilization and disinfection (cds) processes performed at the user facility was requested.Customer provided the following information: device was cleaned, sanitized and disinfected prior to sending the device for repair.Facility was not aware what the foreign material was.The time lag between the end of clinical use and the start of pre-washing noted no delay, properly implemented.Pre-cleaning: flushed the air/water nozzle with water and air.Flushed air/water nozzle with detergent solution.Brushed points for air/water channel performed with clean lint ¿free cloths, brushes, sponges.Facility noted that there was abnormalities on the accessories used for reprocessing but did not provide any details.Facility did not note any comments or concerns regarding reprocessing.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 root cause of the foreign material remaining in the subject device was unable to be specified.Deviation of the reprocessing method from the instruction manual could have caused the foreign material to have remained.The operation manual describes how to inspect for the subject event in ¿chapter 3 preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 inspection of the endoscopic system¿ as below.[inspection of the endoscope] 1 inspect the endoscope connector for any irregularities such as excessive scratching, deformation, and loose parts.4 inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.[inspection of the suction function] 1 depress the suction valve and confirm that water is continuously aspirated into the suction bottle of the suction pump.[inspection of the instrument channel] 1 insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope.2 confirm that the endotherapy accessory can be withdrawn smoothly from the biopsy valve.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, the gastrointestinal videoscope had air/water flow issues.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: foreign material clogging the nozzle.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17436250
• MDR Text Key: 320777788
• Report Number: 9610595-2023-10933
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GIF-H290Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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