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

Model Number CF-EZ1500DL

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

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The customer's complaint was confirmed due to corrosion on plug unit.In addition, the following findings were discovered; the air/water cylinder had no color, the suction cylinder had no color, the endoscopic position detecting unit function did not work due to damage on the endoscopic position detecting unit board, the plug unit had corrosion due to water leakage, the scope connector case unit had corrosion due to water leakage, the play of up/down knob was out of the standard value due to wear of angle wire, the play of right/left knob was out of the standard value due to wear of angle wire, the adhesives around objective lens had white-clouded area, the adhesives around light guide lens had white-clouded area, the adhesive on the bending section cover had a white-clouded area, and the universal cord had a wrinkle.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the colonovideoscope had possible water in the device, an error e315 (non-compatible endoscope) occurred.No patient or procedure was involved.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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 was identified.Based on the results of the investigation, water invaded the scope connector during user handling causing the electrical components to be damaged and the error message e315 was displayed.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: 18322627
• MDR Text Key: 330413712
• Report Number: 9610595-2023-19508
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/15/2024

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: CF-EZ1500DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• 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