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

Model Number OER-PRO

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.(fse) field service engineer was requested to be dispatch to repair the device.To date the fse repair site visit was not yet finalized.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device oer-pro grey scope connector was broken.According to the reporter, they had not processed any scopes after the event.There was no patient involvement on this report, no user harm or injury was reported.

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 probable that the grey connector could not be connected due to some impact was added to the unit and the unit became loose and came apart.Possible causes include stress to the device unit during cleaning design of the device or manufacturing, cannot be confirmed as factors to cause of the event.Ifu(instructions for use) states: do not use the equipment any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation, field service report, device history record (dhr) review and investigation results.Please see updated sections: g4, g7, h2, h3, h6 and h10.The device gray connector, seal, and top water sensor cover were replaced.The equipment was repaired and verified according to oem (original equipment manufacturer) instructions.Software attributes verified.Service record was emailed and provided to customer biomedical representative for record.To date there was no issue or patient harm or injury reported.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The cause of the reported event cannot be conclusively determined.We presume from the investigation results that the gray connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: accumulated stress over time which caused the connector to get loose unintentional impact to the connector with something hard.We could not confirm any factor from the design nor structure of the device that would cause the reported event.Per the instructions for use: 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.Warning do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral device or facilities near the equipment.

• 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: 10270942
• MDR Text Key: 213664760
• Report Number: 8010047-2020-04392
• 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,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1