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

Model Number GIF-PQ260

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

A user facility submitted a repair request to the olympus service center, for an evis lucera gastrointestinal videoscope, having poor water supply.Upon inspection and testing of the returned device, foreign material was found clogged in the scope nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.Additional information was received that the nozzle clogging recurred in several inspections after the repair was completed.The facility requested to identify the cause of the clogging from the viewpoint of preventing recurrence.

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, due to handling (insufficient cleaning), the air and water nozzles are clogged and the draining function reduced, foreign matter clogged in the nozzle, scratches on the insertion tube, flexible tube of the insertion section crushed, insertion tube discolored, scratches found on the operation part, discoloration of the operation part recognized, scratches found on the tip cover, scratches found on switch 1, switch 1 worn out, scratches on operation unit cover, scratches on the up/down knob, scratches on up/down/right/left knob, scratches found on the grip, scratches found on the universal cord, water coverage recognized on the electrical connector, electrical connectors corroded, scratches found on the scope connector, scope connector corroded, scratches found on the scope connector joint case, peeling of the paint recognized on the air/water supply cylinder, and scratches on the right/left angle fixing knob.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.The customer confirmed they cleaned, disinfected, and sterilized the product before sending it to olympus.There was no delay in the start of precleaning.There were no abnormalities in the accessories used for reprocessing.The customer flushed the air/water nozzle with water and air.The air/water nozzle was not wiped/brushed with clean lint-free cloths, brushes, or sponges.The air/water nozzle was flushed with the detergent solution.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, it is likely that the foreign material (identified as polysulfone) remained due to insufficient reprocessing/deviating from the instruction manual.The event can be prevented by following the instructions for use which state: "chapter 3 cleaning, disinfection, and sterilization, procedures, chapter 5 storage and disposal: of the reprocessing manual, especially during reprocessing, please confirm that stain has been removed from the opening of the air/water nozzle and the surface of the objective lens.If any dirt remains, wash until all the dirt is removed, check the handling environment, such as thoroughly rinsing, drying, and removing residual water after reprocessing." 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: 17065465
• MDR Text Key: 317488834
• Report Number: 9610595-2023-08400
• 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,Followup
• Report Date: 07/26/2023

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-PQ260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2013
• 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