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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE
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MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE Back to Search Results
Model Number 6875I
Device Problems Intermittent Continuity (1121); Power Problem (3010); Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Date 11/11/2019
Event Type  malfunction  
Event Description
It was reported that the hana table was continually not operating and would shut down.While trying to disconnect the cable of the foot pedal from the table felt a tingly shock on his elbow when it came in contact with the table.
 
Manufacturer Narrative
Abnormal use.Coatomer was previously advised that the foot pedal was damaged beyond repair and should not be used.In spite of the warning, the customer attempted to repair it and continued using it.
 
Event Description
It was reported that the table was continually not operating and would shut down.While trying to disconnect the cable of the foot pedal from the table for cleaning after the procedure, the technician felt a tingly shock on his elbow when it came in contact with the table.
 
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Brand Name
HANA
Type of Device
SURGICAL OPERATING TABLE
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city, ca CA 94587 1234
MDR Report Key9330501
MDR Text Key183889016
Report Number2921578-2019-00046
Device Sequence Number1
Product Code JEA
UDI-Device Identifier00842430108747
UDI-Public00842430108747
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6875I
Device Catalogue Number6875I
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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