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

Model Number CF-EZ1500DL

Device Problem Mechanical Problem (1384)

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

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

The device was returned and during the evaluation the angulation knob and bending angle did not meet specification.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported the scope experienced a snapped angulation wire.A 37 minute delay was reported during the diagnostic colonoscopy resulting in increased sedation time.The procedure was completed using a similar device.

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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the procedure was delayed due to the defective angulation of the device.During inspection of the device, it was observed that the up/down control knob could not be engaged (non-reportable malfunction); however, it was confirmed that there was no breakage or abnormality of the angulation wire (a-wire).Therefore, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in section: ¿operation manual: chapter 3.Section 3.3 inspection of the endoscope: inspection of the bending mechanisms.¿ this supplemental report includes a correction to d9 and g2 from the initial medwatch.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: 18812890
• MDR Text Key: 336620387
• Report Number: 9610595-2024-04306
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• 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: 02/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• 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
• Patient Outcome(s): Other