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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

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OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-4
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc performed analysis of component of the white crystalline material, oxygen, carbon and silicon were detected mainly.Therefore the it was considered that the white crystalline material was mixture of the peracetic acid (disinfectant solution) and some kind of silicone-based material which might be antifoam agent or other medical agent.It was considered that there was the possibility that these might be mixed into the reprocessing basin, or these could not be rinsed completely then remained in the reprocessing basin.However the exact cause of the reported event could not be conclusively determined.If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed from the user that despite the user used the subject device as per normal, the white crystalline material had become to adhere thickly to the reprocessing basin of the subject device along the retaining rack.The user found the above issue during the reprocessing.The subject device had functioned without any problem.There was no report of patient injury associated with the event.
 
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Brand Name
OER-4 100V
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 Key11587597
MDR Text Key242894489
Report Number8010047-2021-04340
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 user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/30/2021
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-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/05/2021
Initial Date FDA Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2017
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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