MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-3 100V; ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

The jelly-like foreign material found in the washing case, and device were returned to omsc for component analysis.The user requested confirmation of whether the foreign material found was from an endoscope or reprocessor.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the preparation for use before reprocessing, a transparent jelly-like foreign material was found in the washing case of the reprocessing basin.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) analyzed the components of the jelly-like foreign material sent from the user facility and found that it approximated the waveform of water.In addition, when the foreign material was dried and the components of the dried residue were analyzed, it was found that it approximated the waveform of glycerol (glycerin).Therefore, it was found that the foreign material is a mixture containing water and glycerol as the main components.From the above, foreign material can be like a lubricant or lotion.Specifically, it is possible that it is endolubri, which is a lubricating jelly that is applied to endoscopes and other instruments during endoscopy.The reported event may have been caused by the fact that the applied endolubri was not sufficiently removed by precleaning, etc., and thus entered the reprocessing basin and remained in the washing case during cleaning.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: OER-3 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 11853516
• MDR Text Key: 268372367
• Report Number: 8010047-2021-06524
• Device Sequence Number: 1
• Product Code: FEB
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1