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

Model Number CF-EZ1500DI

Device Problems Corroded (1131); Failure to Clean Adequately (4048)

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

Event Date 01/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and in addition to the reportable malfunction documented in b5, the remaining evaluation findings were as follows: due to wear of scope cover, water tightness was lost; flexibility adjustment ring, switch box, objective lens, and grip had a scratch; light guide lens had a crack and scratch; air/water cylinder and suction cylinder had no color; due to wear of angle wire, the play of up/down knob was out of the standard value; connecting tube had coating peeling; universal cord had a wrinkle; and screw stopper was replaced for preventive maintenance.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.

Event Description

The customer reported to olympus, the colonovideoscope had possible water ingress, no image.The device was returned for evaluation.During testing and inspection of the device, the following reportable malfunction was found: jet tube had foreign objects (white foreign material) and plug unit corroded resulting in communication error e315.There were no reports of patient harm or impact associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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: 18655982
• MDR Text Key: 334839733
• Report Number: 9610595-2024-02606
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 01/23/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2021
• 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