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

Model Number OER-PRO

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by the service technician which identified a connector/valve/filter issue: connecting tube cannot be connected, breakage of the connector in the basin and problems with connection to connecting tube.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported the gray connector of the unit was damaged (the one gray connector in the basin of the unit was missing the center piece to it).The field service engineer replaced both gray connectors which resolved the issue.There was no patient injury reported at the time of the call.

Manufacturer Narrative

This report is being supplemented to provide additional information (e2, e3, h10) regarding the reported event.Additional information received confirmed there was no harm or injury to staff related to this event.The reported event was noticed after a procedure.Per the customer, there was a 2.5 hour delay in procedures.There was one patient that could have potentially been at risk due to the failure.The patient was notified.According to the olympus infection control personnel, it was determined that was not a factor.Per the customer, all necessary protocol was completed.Additionally, testing was completed per the physician.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.Instructions for use (ifu) states: ¿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.¿ the cause of the event cannot be conclusively determined.Possible causes include: an impact that was caused to the unit causing it to become loose or to come apart.

• 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: 10278646
• MDR Text Key: 223651298
• Report Number: 8010047-2020-04448
• 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,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1