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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 Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Event Description
The user returned the forceps/irrigation plug maj-891 to olympus because of a leakage from the plug maj-891. When the user replaced it with another plug, there was no problem, and the same phenomenon occurred with the same type of plug maj-891 on the same day at the user facility. Olympus medical systems corp. (omsc) inspected the vicinity of the part where the watertightness of the plug maj-891 was not maintained, and found that foreign material was adhered to the mating surface between the male part of the stopcock and the stopcock part. Therefore, the poorly reprocessed plug maj-891 may have been used in the procedure. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The forceps/irrigation plug maj-891 was evaluated at omsc. Omsc checked the watertightness of the forceps/irrigation plug and found that air bubbles were leaking near the stopcock. Furthermore, omsc confirmed the vicinity of the part where the watertightness was not maintained, and found that foreign material was adhered to the mating surface between the male part of the stopcock and the stopcock part. Therefore, it is possible that water leakage from the forceps/irrigation plug occurred due to the change in the watertight condition between the male part of the stopcock and the stopcock part. Omsc attempted to analyze the composition of foreign material, but could not analyze it due to the small amount of sample. Osmc was unable to review the device history record because the lot number and manufacturing date of the forceps/irrigation plug maj-891 are unknown. If additional information becomes available, this report will be supplemented.
 
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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 Key12945399
MDR Text Key285982295
Report Number8010047-2021-15627
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMAJ-891
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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