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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-5
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
The connector of the subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed that a translucent and stretchy foreign material was inside the connector.The foreign material came from the component of the silicone series based on a component analysis.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.There was no cause in the manufacturing process of the subject device.The exact cause of the reported phenomenon could not be conclusively determined.There was the possibility that the foreign material of silicon had entered the pipeline of the subject device from the outside at some time.
 
Event Description
Olympus medical systems corp.(omsc) was informed from the user that before reprocessing of endoscope, the user found that the air/water/instrument channel connector (gray) of the subject device was clogged with a foreign material like a transparent adhesive.A local service engineer repaired the subject device at the facility.The user thought that there was low possibility of the insufficient reprocessing of endoscopes since it was found before the endoscope was reprocessed.Other detailed information was not provided.There was no report of patient injury associated with the event.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12237259
MDR Text Key270065466
Report Number8010047-2021-09460
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/28/2021
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-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/05/2021
Initial Date FDA Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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