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

Model Number GIF-H260

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

The evis lucera gastrointestinal videoscope was returned to an olympus service center for evaluation with a report that there was a pinhole leak.There was no patient or user harm reported due to this event.Inspection and testing of the subject device found the nozzle was clogged with foreign material.This report is being submitted for the malfunction found during the device evaluation.

Manufacturer Narrative

The customer stated that the subject device was cleaned, disinfected, and sterilized the device before sending to olympus: there was no delay in the start of precleaning, the customer flushed the air/water nozzle with water and air during cleaning, the customer wiped/brushed the air/water nozzle with clean lint-free cloths, brushes, or sponges; the air/water nozzle/channel were flushed with the detergent solution.The device evaluation found a pinhole leak in the connecting tube.Due to the clogging of the nozzle, water removal did not meet specifications.The adhesive on the bending rubber was cloudy, the camera cover was dented, the insertion tube was caught/pinched/deformed; the connecting tube had wrinkling, and the resin was cracked due to chemical stress from the cleaning/disinfecting/sterilization processes over time.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

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.Based on the results of the investigation, the foreign material was unable to be identified and the root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu): the instruction manual evis lucera gif/cf/pcf type 260 series describes how to detect for the suggested event in chapter 3 preparation and inspection.The instruction manual evis lucera gif/cf/pcf type 260 series reprocessing manual describes how to prevent for the suggested event in chapter 3 cleaning, disinfection, and sterilization procedures.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: 17683094
• MDR Text Key: 322639704
• Report Number: 9610595-2023-12699
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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: 08/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2004
• 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