MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-ELITE

Device Problem Decrease in Pressure (1490)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) determined while evaluating the device issue onsite, that the flushing of the adjacent toilets was creating a drop in the water pressure and flow.The facility dialed back the pressure on the toilets nearest to the device and the pressure and flow drop appears to have been eliminated.The facility is monitoring the issue for updates.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, the e61 error message was being observed for the device every two-three cycles.The field service engineer (fse) reproduced this error message.The fse observed that the water supply supplied to the device was shared by the adjacent bathroom.The flushing of the adjacent toilets was creating a drop in the water pressure and flow.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Due diligence was executed for this event with no information, including initial reporter occupation, available.The device history record review could not be performed since the serial number of the device is not known.It is inferred that the water supply pressure became inadequate due to issue of water supply source at the facility.It is likely that the fluid level sensor may have turned off temporally since fluid level in the basin was changed during ultrasonic cleaning due to improper pressure of the water tap in the facility.This may have caused occurrence of e61.The instructions for use (ifu) includes the following statements which can prevent the issue of water pressure from happening: 4.1 installation conditions water supply conditions ifu description relating to e61 error: 13.2 troubleshooting guide ultrasonic cleaning in not functioning irregularity in the ultrasonic oscillator contact olympus.

• Brand Name: ENDOSCOPE REPROCESSOR
• 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: 12417198
• MDR Text Key: 273836804
• Report Number: 8010047-2021-11167
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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-ELITE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1