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

Model Number OER-ELITE

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) visited the facility to observe the cracked lid and determine the cause.During this visit, the customer reported to the fse that the handle on the washing case wasn't in the open groove in the washing rack holder and placed in a crooked fashion.The user closed the lid and started a cycle.When the cycle started pressure from the washing case port caused the clear plastic lid to crack.The customer was informed that there were no replacement parts for this model and that the device needed to be exchanged.If additional information is obtained, a supplemental report will be filed.

Event Description

A nurse administrator at a user facility reported that a cracked lid was discovered on a model oer-elite before a procedure.The lid was not properly seated when the lid was closed.The machine was being shut down for the day when this happened.There was no leaking associated with this event and no scopes were being reprocessed when this occurred.No other devices were involved in the event.There was no patient involvement, harm or procedural delay reported.No other information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and to correct data included in the initial report.A review of the device history record confirmed the subject device was shipped in accordance to specifications.Based on the results of the legal manufacturer's investigation, the phenomenon occurred because the user closed the lid without setting the washing case properly in the retaining rack.A review of the instructions for use confirm the phenomenon is detectable per section '5.5 inspection of the lid and lid packing': "before using the reprocessor, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.".

• 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: 11164250
• MDR Text Key: 243486414
• Report Number: 8010047-2021-01329
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• PMA/PMN Number: K201920
• 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: 02/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1