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

Model Number CF-EZ1500DL

Device Problems Image Display Error/Artifact (1304); Communication or Transmission Problem (2896)

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

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The device was returned to olympus for evaluation, and the customer's allegation was confirmed.Additionally, the evaluation found corroded pins/light guide (light guide) cracked from shock damage.A follow-up with the user facility is currently being performed.The root cause could not be determined, the investigation is pending.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported to olympus, during preparation for use, for an unspecified procedure, error 315 occurred on the colonovideoscope.There was no patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report, to provide information that was inadvertently left out of the initial medwatch, and to provide additional information based on the legal manufacturer's final investigation.Corrected fields: b5, e1 (telephone), g2 (country name), h6 (component code and medical device problem code), h10 (evaluation details).During inspection and testing, the reported issue (e315 error code) was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over a year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely that e315 error was temporarily displayed at the facility due to malfunction of electrical parts due to water entering the inside of the plug unit while the user was handling it.However, a definitive root cause could not be determined.In addition, service found the connecting tube was scratched and the bending angle in down direction was out of specification due to wear of the angulation wire.Per the legal manufacturer, these defects and other device defects included in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

Event Description

Additional information that was inadvertently left out of the initial medwatch: reportedly, the device was cleaned.However, the issue (e315 error ¿ scope error) persisted.

• 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: 16440982
• MDR Text Key: 310383467
• Report Number: 9610595-2023-03275
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2023
• 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: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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