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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) FORCEPS/ IRRIGATION PLUG

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OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG Back to Search Results
Model Number MAJ-891
Device Problems Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to omsc for evaluation. Omsc checked the subject device and found that there was the brown foreign material on the joint portion of the stopcock. As a result of the analysis of component, the brown foreign material was corrosion. Omsc concluded that the metal part of the stopcock was corroded and then the gap generated on the joint portion, consequently the lever became looser than an initial product. Omsc also concluded that the corrosion on the joint portion of the stopcock was caused by the oxidation due to the residue of chemicals. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user facility that while disassembling the subject device during the reprocessing, it was found that the lever of the subject device was looser than usual. The user facility did not provide other detailed information. There was no report of patient injury associated with this event.
 
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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 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 Key10991203
MDR Text Key220981632
Report Number8010047-2020-10230
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAJ-891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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