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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K CAMERA HEAD
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SHIRAKAWA OLYMPUS CO., LTD. 4K CAMERA HEAD Back to Search Results
Model Number CH-S400-XZ-EB
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported, the camera head was not connecting.The issue occurred during procedure, and the lap hysterectomy procedure was completed with a similar device.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned, and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
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Brand Name
4K CAMERA HEAD
Type of Device
CAMERA HEAD
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19004920
MDR Text Key339146405
Report Number3002808148-2024-31795
Device Sequence Number1
Product Code FET
UDI-Device Identifier04953170374609
UDI-Public04953170374609
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172817
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCH-S400-XZ-EB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2024
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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