MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the field service engineer checked the subject device and found that the subject device was not able to discharge the detergent because the detergent had stuck in the inside the line before the use.For the first time after a long interval, the facility was going to use the subject device.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation, it was found that the diaphragm pump was operating normally, but detergent residue was on the propeller in the sensor and was stuck.Omsc reviewed the manufacturing history record (dhr) of the subject device and confirmed no irregularity.The sensor had been sticking with the residue of the detergent, therefore the sensor did not function.The residue of the detergent was removed, then the sensor functioned properly.It was considered that this phenomenon was attributed to the sticking of the residue of the detergent due to long time disuse.Olympus stated the appropriate maintenance of oer-4 and the counter measures against abnormalities in the instruction manual of oer-4.

• Brand Name: OER-4 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
• MDR Report Key: 10151319
• MDR Text Key: 203893500
• Report Number: 8010047-2020-03337
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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: Other
• Device Model Number: OER-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/13/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1