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

Model Number OER-PRO

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The field service engineer on site repaired the device by replacing the yellow basin auxiliary scope spring connector.Once completed, the device was tested and passed all required testing and specifications.

Event Description

It was reported that the device oer-pro aux connector was broken and would not connect.According to the reporter the issue was observed during the reprocessing.There was no patient involvement on this report.

Manufacturer Narrative

The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The cause of the event cannot be conclusively determined.It is presumed that the yellow connector was broken/loose due to some impact to the yellow connector unit.The unit became loose and came apart.It may have caused the connecting tube to be impossible to be connected fully, which then disconnected during reprocessing.Design of the device or manufacturing, cannot be confirmed as factors to cause of the event.The instructions for use state: "at the end of the reprocessing cycle, check each connecting tube prior to removing the endoscope from the reprocessing basin.If any connecting tube is kinked, or any connecting tube is not attached at both (all) ends, repeat the entire oer-pro reprocessing cycle from the beginning.A kinked or unattached connecting tube will prevent the channels of the endoscope from receiving sufficient fluid flow to achieve proper cleaning and disinfection.Any irregularity in the use of the connecting tubes (improper connecting, kinking, accidental detachment, use of the wrong connecting tube) will cause the oer-pro reprocessing cycle to become ineffective.The irregularity must be corrected, and the endoscope must be reprocessed again under correct conditions".Olympus will continue to monitor complaints for this device.

• 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: 10239536
• MDR Text Key: 213498632
• Report Number: 8010047-2020-03964
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1