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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. PRECAUTIONS OF USING THE STERILIZATION CAP

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OLYMPUS MEDICAL SYSTEMS CORP. PRECAUTIONS OF USING THE STERILIZATION CAP Back to Search Results
Model Number MAJ-1538
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 03/31/2020
Event Type  Injury  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed that a nurse of the user facility injured his or her finger when he or she attached the subject maj-1538 (sterilization cap) to the endoscope ltf-s190-5 during reprocessing.The user facility did not provide other detailed information.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
 
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Brand Name
PRECAUTIONS OF USING THE STERILIZATION CAP
Type of Device
STERILIZATION CAP
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10000650
MDR Text Key189727864
Report Number8010047-2020-02393
Device Sequence Number1
Product Code EOB
UDI-Device Identifier04953170233012
UDI-Public04953170233012
Combination Product (y/n)N
PMA/PMN Number
K061313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMAJ-1538
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/31/2020
Initial Date FDA Received04/27/2020
Supplement Dates Manufacturer Received09/10/2020
Supplement Dates FDA Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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