MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE COLONOVIDEOSCOPE

Model Number PCF-H290I

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that preparation for use, the black foreign material came out from the air/water nozzle of the endoscope when air/water supply.The same event occurs frequently, but the model and serial number cannot be identified.The device had been reprocessed with an olympus automated endoscope reprocessor model oer-4 (not available in the usa) using peracetic acid.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

The foreign material will be returned to olympus for evaluation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The foreign material was returned to olympus medical systems corp.(omsc) for evaluation.Omsc could not review the device history record because the subject device is unknown.There is possibility that the foreign material is a mixture of cellulose and protein.There is the possibility that the cellulose came from the component of molds and cellulosic chemicals, etc.There is the possibility that the protein came from the component of living body, bacteria, protein-based chemicals, etc.The exact cause of this event could not be conclusively determined.Olympus medical systems corp.(omsc) surmised that the reported phenomenon occurred due to the following cause.- the foreign material entered the air/water channel and the foreign material was not removed due to insufficient cleaning and rinsing.

• Brand Name: EVIS LUCERA ELITE COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13086919
• MDR Text Key: 286854271
• Report Number: 8010047-2021-16884
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H290I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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