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.

• 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

• Date FDA Received: 12/13/2023
• 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
• Date Manufacturer Received: 03/13/2024
• 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