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

Model Number OER-PRO

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Customer stated she was advised to contact olympus technical assistance center (tac) to walk her through changing the pre-filters when ready.Tac explained the maj-824 filter has to be changed every six months.Tac explained how the pressure drops on the prefilter and how to make an adjustment.Tac emailed customer the consumable list with instructions and part numbers for filters.Tac directed customer how to find steps on how to change the six month filter and provided the olympus web site information of how to download quick reference guide.Issue resolved over tac phone call.No further information was reported.

Event Description

The customer called olympus for guidance on changing the filter in the oer-pro.The user reported that the filter was being changed for the first time one week short of a year.The customer was not aware of the frequency for changing the filters.There was no patient injury reported.

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: ¿replace the water filter at least once a month to prevent contamination of the rinse water.Using at least a prefilter (0.45 micron or less) can extend the life of the water filter.¿ during the investigation it was confirmed that the device had been used at the user facility longer than the recommended period.Related to report mfr: 8010047 -2020 - 05620.

• 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: 10427916
• MDR Text Key: 223647086
• Report Number: 8010047-2020-05619
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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