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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER Back to Search Results
Model Number MAJ-2315
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2018
Event Type  malfunction  
Manufacturer Narrative
Olympus medical systems corp.(omsc) investigated reported phenomenon with using a similar device.Omsc confirmed that twisting or pulling the cover attached on the scope didn't cause any damages as long as it's properly attached.The exact cause of the reported event could not be conclusively determined.However, omsc surmised that the distal cover was damaged when the user attached it to the scope.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
During endoscopic retrograde cholangiopancreatography (ercp), the user used tjf-q190v with the subject device.When the user withdrew the tjf-q190v, the subject device fell off into the patient's esophagus.The user picked up the subject device from the patient's body.The user confirmed that the subject device was broken not only the rear end of the front cover but also the front end.There were no reports of patient injuries related to this incident.
 
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Brand Name
SINGLE USE DISTAL COVER
Type of Device
DISTAL COVER
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 Key9999809
MDR Text Key203696354
Report Number8010047-2020-02388
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/27/2020
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 No Information
Device Model NumberMAJ-2315
Device Lot Number8523H
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/03/2020
Initial Date FDA Received04/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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