• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-PRO
Device Problems Break (1069); Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to replace the damaged lid and broken connector.The device passed all the service inspections.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 and a broken grey connector on an oer-pro endoscope reprocessor.No patient involvement or injury was reported.No additional information has been obtained.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer's investigation.A review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted as part of the investigation.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.Possible causes of the connector breaking include user added stress or impact with a hard object, causing the connector to become loose then break.Possible causes of the cracked lid include contact with a scope/hard object or age deterioration.The ifu contains the following statements that may prevent connector breakage: "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." the ifu contains the following statements that may prevent a cracked lid: "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." olympus will continue to monitor the field performance of this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11339674
MDR Text Key232804158
Report Number8010047-2021-02771
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,health
Type of Report Initial,Followup,Followup
Report Date 04/16/2021
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 01/21/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received03/26/2021
04/16/2021
Supplement Dates FDA Received04/14/2021
04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-