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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-PRO
Device Problems Device Alarm System (1012); Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to investigate the issue.When the fse arrived on site, he replaced the broken grey connector.The acecide was drained and replaced without error.The fse discovered a slow leak inside the device that was caused by a cracked fluid level sensor in the tub.The fluid sensor was replaced, and some stains were cleaned inside the unit.The device was repaired according to specifications and electrical safety check was performed.If additional information is obtained a supplemental report will be filed.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
 
Event Description
A user facility reported error codes: irregularity in the fluid level sensor in the disinfectant tank e76 and insufficient amount of disinfectant in the disinfectant tank e12 during a cycle on an endoscope reprocessor.In addition, a broken grey connector was also reported.No patient involvement or injuries were reported.No additional information has been obtained.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g4, g7, h2, h3, h4, h6, and h10.A review of the device history record confirms the subject device was shipped in accordance with specifications.Based on the results of the investigation, the connecting tube cannot be connected to the device due to breakage of the connector in the basin.The breakage is likely due to age deterioration and added stress on the connector to loosen it, or a hard object hit the connector.Based on a review of the instructions for use, the following is identified in section 3.3 'inspecting the connectors': "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".Per the legal manufacturer, the other issues identified in the initial report (slow leak inside the device caused by a cracked fluid level sensor in the tub and stains inside the unit) have no potential to cause or contribute to death or serious injury if they were to recur.
 
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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 Key10993135
MDR Text Key220982429
Report Number8010047-2020-10244
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170258589
UDI-Public04953170258589
Combination Product (y/n)N
PMA/PMN Number
K103264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOER-PRO
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received12/11/2020
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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