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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)

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OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) Back to Search Results
Model Number MAJ-891
Device Problem Device Contamination With Biological Material (2908)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp. For evaluation. The subject device was replaced with a new one. The user commented that the cleaning has not been sufficient for the narrow part of inside the subject device. The user facility reportedly improved the cleaning process to conduct as shown in the instruction manual and a culture test will be conducted in order to confirm the improvement effect. The exact cause of the event could not be conclusively determined at this moment, but insufficient cleaning will be a possible cause as the user commented.

 
Event Description

Olympus was informed that a few older people who underwent cystoscopy as outpatients were infected. The user facility conducted culture test for the subject device and a cystoscope (olympus visera cysto-nephro videoscope cyf-va2, serial number: (b)(4)) concomitantly used with the subject device. Esbl-producing bacteria was detected from the subject device, but no microorganisms were detected from the scope. There was no other information obtained.

 
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Brand NameFORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
Type of DeviceFORCEPS/IRRIGATION PLUG
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6590084
MDR Text Key75916019
Report Number8010047-2017-00640
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMAJ-891
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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