MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-AW 220V (BRA); ENDOSCOPE REPROCESSOR

Model Number OER-AW

Device Problems Break (1069); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to 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 from the user that during unspecified timing the water was not filled.During the incoming inspection for repair at the service department of olympus (b)(4), it was found that the malfunction of the dilution valve due to the broken internal connector.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 not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus korea (okr).Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based on the information from okr, there was the possibility that this phenomenon was attributed to the followings.The normal opening/closing might be hampered by clogging of the valve inside the dilution valve.- the electrical circuit board controlling the movement of the valve inside the dilution valve might be damaged due to the overcurrent generating on the connector of the dilution valve.

• Brand Name: OER-AW 220V (BRA)
• 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: 11325949
• MDR Text Key: 233382149
• Report Number: 8010047-2021-02589
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/18/2021

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: No Information
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/13/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1