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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 Problem Break (1069)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse replaced the broken grey connector.The device was repaired to specifications.The device passed all the functional and electrical safety tests.Software attributes were verified and confirmed.No other issues were reported.If additional information is obtained a supplemental report will be filed.
 
Event Description
A user facility reported a broken grey connector on an endoscope reprocessor.The problem was first noticed before use - reprocessing.No other devices were involved in the event.There was no leaking associated with this event.This event did not involve a case/procedure or patient.There were no patient infections or scopes with positive cultures as a result of the broken connector.No additional information has been obtained.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: d8, g3, g6, h2, h4, h6, h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively determined.Based on the results of the investigation, it is likely the gray connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: accumulated stress over time which caused the connector to get loose.Unintentional impact to the connector with something hard.We could not confirm any factor from the design nor structure of the device that would cause the reported event.Per the instructions for use: ¿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.¿ and ¿warning -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.¿.
 
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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 Key11318223
MDR Text Key233560402
Report Number8010047-2021-02537
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 05/06/2021
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 01/18/2021
Initial Date FDA Received02/11/2021
Supplement Dates Manufacturer Received05/06/2021
Supplement Dates FDA Received05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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