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

Model Number OER-ELITE

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) assisted the customer with troubleshooting.Tac informed the customer that the reported errors codes meant the following: ¿e014¿ disinfectant solution is not recovered, ¿e005¿ the electrode water level sensor or the float switch in the reprocessing basin indicates overflow level and the ¿e012¿ fluid level in the disinfectant tank is decreased to a low level.All were associated with the liquid chemical germicide ¿lcg¿ and a connector that needed to be replace immediately on the 5th day channel monitoring errors would occur.The customer was able to resolve the reported issue without further assistance.In addition, as part of our investigation of this report, an olympus field service engineer (fse) was dispatched to the user facility to assess their reprocessing practices with the oer-elite and to provide reprocessing training if necessary.To date, the fse visit has not been finalized.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during reprocessing the oer-elite displayed multiple errors ¿e014, e005 and e014 due to a connection issue.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Please see the updates in sections.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11768613
• MDR Text Key: 276383398
• Report Number: 8010047-2021-05798
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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-ELITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1