MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. COLONOVIDEOSCOPE

Model Number CF-EZ1500DI

Device Problems Corroded (1131); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's reported issue ¿device not recognized by the processor¿ was confirmed.The following findings were also noted during device evaluation: due to a crack on scope-body, water tightness is lost, due to damage on up/down knob, water tightness is lost, due to deformation of angle shaft, up/down knob does not move smoothly, suction-cylinder has discoloration, the cover of light guide-bundle is damaged, due to damage on bending section, insulation resistance value at distal end does not meet specifications, due to wear of angle wire, bending angle in up direction does not meet specifications, light guide lens has a crack, connecting tube has a scratch, and universal cord has a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that the colonovideoscope was not recognized by the processor.Upon inspection and evaluation, this was due to corrosion on plug unit, e315 (scope err unsupported scope) occurs.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, a definitive root cause of the observed e315 image issue could not be determined, however, the issue was likely due to device leaked into the scope connector during user handling/mishandling, resulting in an electronic components malfunction.The event can be detected/prevented by following the instructions for use (ifu) which states: chapter 3 preparation and inspection: the equipment prepared before using this endoscope and procedures for inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection.The workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning¿ never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk.Chapter 5 troubleshooting: the countermeasures against troubles are described in this chapter.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Warning¿ never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk.Olympus will continue to monitor field performance for this device.

• Brand Name: COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 17822635
• MDR Text Key: 324327438
• Report Number: 9610595-2023-14118
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-EZ1500DI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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