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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. FOOT SWITCH
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SHIRAKAWA OLYMPUS CO., LTD. FOOT SWITCH Back to Search Results
Model Number MH-317
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2023
Event Type  malfunction  
Event Description
It was reported the foot switch is not working and the pressure decreased.The issue occurred during an unspecified therapeutic procedure.The procedure was completed with a similar device and there were no reports of patient harm.
 
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
FOOT SWITCH
Type of Device
FOOT SWITCH
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 Key19086490
MDR Text Key340703338
Report Number3002808148-2024-03388
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170053627
UDI-Public04953170053627
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K953162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMH-317
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MH-317 FOOTSWITCH; UHI-3 INSUFFLATION UNIT; UHI-3, MH-317
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