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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-ELITE
Device Problem Disconnection (1171)
Patient Problem No Patient Involvement (2645)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse put the broken connector back together.The device was repaired to specifications.No other issues were reported.If additional information is obtained a supplemental report will be filed.
 
Event Description
A user facility reported that a connector came apart on an endoscope reprocessor.There was no patient involvement or injuries reported.No additional information has been obtained.
 
Manufacturer Narrative
As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be established.It is likely the lock lever received extra stress by being pushed to connect to the connector when the user attached the connecting tube.This would cause the lock lever to break off and prevent the connecting tube from being attached.The ifu contains the following statements regarding the connecting tube that may help prevent misuse: "if there is an irregularity of the connecting tube on either endoscope, it must be corrected and both endoscopes must be reprocessed again.Otherwise, the reprocessing of endoscopes may be insufficient." olympus will continue to monitor the field performance of this device.
 
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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 Key11316776
MDR Text Key233559131
Report Number8010047-2021-02532
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170404047
UDI-Public04953170404047
Combination Product (y/n)N
PMA/PMN Number
K201920
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 09/17/2021
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-ELITE
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/15/2021
Initial Date FDA Received02/11/2021
Supplement Dates Manufacturer Received09/01/2021
Supplement Dates FDA Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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