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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 Crack (1135)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to replace the damaged lid.The device was repaired following specifications.Software attributes have been 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 that a lid was cracked on an oer-pro endoscope reprocessor.No patient involvement or injury was reported.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.Probable causes for a cracked lid include: the lid contacting with a scope when it was closed, an external impact to the lid and/or a chemical crack due to adhered chemical solution which was not removed.The design of the device and the manufacturing process cannot be confirmed as factors to cause the event.The most probable cause for the reported event is user handling.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.Per the instructions for use (ifu): before using the equipment, 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.The lid is not cracked, broken, or otherwise damaged.
 
Manufacturer Narrative
This supplemental report is being submitted to provide further information from the manufacturer's investigation.Upon additional investigation, it was found the root cause of the cracked lid was the user closing the lid on the tube.The users were retrained by an olympus field service engineer.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 Key11337271
MDR Text Key232801601
Report Number8010047-2021-02750
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,Followup
Report Date 04/27/2021
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 01/20/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received03/18/2021
04/08/2021
Supplement Dates FDA Received03/19/2021
04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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