MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE; FLEXIBLE VIDEO COLONOSCOPE, REUSABLE¿

Model Number PCF-H190DL

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the evis exera iii colonovideoscope, giving e315 error scope.The issue was noted during reprocessing.Intended procedure was diagnostic.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.Fluid invasion was found in the scope connector causing the reported issue.There were also dents and scratches on the distal end cover, cracked light guide lens, damaged glue and play in the control knobs.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to water invasion of the scope connector while the user was handling the device which led to abnormality of electronic parts.As a result, error message was displayed.The user may detect the suggested event by handling the device in accordance with the following instructions for use (ifu): "inspection of the endoscopic image" user may reduce/prevent occurrence of the suggested event by handling the device in accordance with the following ifu: "when attaching the connector cap of the leakage tester (mb-155) to the venting connector of the endoscope, make sure that both the connector cap and the venting connector are thoroughly dry.Water on the surface of either component may enter the endoscope and could cause endoscope damage.Do not attach/detach the leakage tester while the endoscope is immersed.Attaching/detaching under water could allow the water to enter the endoscope, resulting in endoscope damage." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO COLONOSCOPE, REUSABLE¿
• 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: 16644697
• MDR Text Key: 312493324
• Report Number: 9610595-2023-05312
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• 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