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

Model Number OER-3

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject oer-3 has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The air/water/instrument channel connector (gray) detached from the reprocessing basin of the oer-3.The user is not sure when the connector started getting loose.The user reported that sometimes water remained in the channels of endoscopes after reprocessing cycle ends.There was no patient injury report related to the event.

Manufacturer Narrative

Olympus medical systems corp.(omsc) could not investigate the subject oer-3, because the subject oer-3 was not returned to omsc.The subject device had been repaired.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Since the subject device was not returned, the exact cause was not determined; however, the following are potential cause.Based on the similar case, the user repeatedly applied a rotational force to the connector of the reprocessing basin of the subject oer-3.The instruction manual of the subject device states the corresponding method in case of an abnormality.Warning: do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Inspection: check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.

• 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: 9096587
• MDR Text Key: 216357272
• Report Number: 8010047-2019-03340
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2016
• 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