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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 Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
As reported, when the device was disassembled , a presence of abnormal coloring and fragments on the equipment was observed. The issue found during an unspecified procedure. There was no patient injury reported due to the event.
 
Manufacturer Narrative
The subject device was not returned for evaluation. Follow ups were made however, were unsuccessful, no response is received from the customer. Investigation is ongoing. This report will be supplemented accordingly following investigation. Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
 
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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 Key13311545
MDR Text Key295347681
Report Number8010047-2022-01750
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170063114
UDI-Public04953170063114
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAJ-891
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2022
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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