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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed from the user that during an unspecified surgery assisted by endoscopy using the subject device for the patient, who suffered from cerebral infarction, left renal ureteral calculi with hydronephrosis, and infection, it was found that fluid was the spurted out from the connector of the subject device. Then, the user replaced the subject device with another similar device to complete the intended procedure. In addition, the user stated that the sealing ring of the subject device had been damaged, so the sealing ring was replaced to a new one, and the subject device could be used normally. There was no report of patient injury associated with this event.
 
Manufacturer Narrative
The subject device has not been returned to any of the olympus locations. Therefore, olympus could not investigate the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, 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 Key12982603
MDR Text Key286132144
Report Number8010047-2021-16013
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMAJ-891
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2022
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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