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

Model Number OER-PRO

Device Problems Break (1069); Defective Device (2588); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to the user facility to complete a device evaluation and repair.The fse replaced the grey connectors.Once completed, the device was tested and passed all required testing and specifications.As stated on the ifu and as a preventive measure, the user manual states: the oer-pro requires routine maintenance and inspection.In addition to checks before use, the person in charge of maintenance and administration of the medical equipment at the hospital should periodically check all of the items described in this manual.If any irregularity is observed, do not use the equipment and inspect it as described in 8.1, ¿troubleshooting guide¿ on page 274.If the irregularity is still present, the equipment must be repaired prior to next use.

Event Description

It was reported that the oer-pro grey connector was broken.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr).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 root cause of the event cannot be conclusively determined.It was presumed that the gray connector unit came apart and may have caused disconnection of the connecting tube.The user may have added stress to the gray connector.The stress may have caused the event.Design of the device or manufacturing, cannot be confirmed as factors to cause of the event.It was presumed that the user added stress toward the direction to the connector get loose, which led to the event.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.

• 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: 10379339
• MDR Text Key: 202035654
• Report Number: 8010047-2020-05385
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1