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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1837 CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES
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OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1837 CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES Back to Search Results
Model Number MAJ-1837
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 05/06/2020
Event Type  malfunction  
Manufacturer Narrative
There is no additional information about the event as yet.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
 
Event Description
As reported for this event, during maintenance reprocessing the device would not detach from the light source device.There was no problem observed with the light source device when disconnecting with the scope.There was no patient involvement.
 
Manufacturer Narrative
Upon further review this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
MAJ-1837 CONNECTING TUBE
Type of Device
ENDOSCOPE REPROCESSOR ACCESSORIES
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10102041
MDR Text Key223213606
Report Number8010047-2020-02981
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
PMA/PMN Number
K120357
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 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMAJ-1837
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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