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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ; HEAD POSITIONING UNIT
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MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ; HEAD POSITIONING UNIT Back to Search Results
Model Number 7887-050
Device Problems Electrical Shorting (2926); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2019
Event Type  malfunction  
Event Description
It was reported that 30 to 45 minutes into this case the surgeons noticed that the head of the patient was slowly moving downward.One surgeon had to break scrub to stop it from moving down any further while the other surgeon held the patient's head at the skull clamp.
 
Manufacturer Narrative
It is evidence through the investigation of the returned unit, that some fluid ingress caused short circuit between the connector and the wires.This resulted in the joints to remain open and not hold in lock position.The ball joint appears to have over heated and damage the ball joint motor.It is unknown if proper cleaning method as instructed in the owner's manual was applied.
 
Event Description
It was reported that 30 to 45 minutes into this case the surgeons noticed that the head of the patient was slowly moving downward.One surgeon had to break scrub to stop it from moving down any further while the other surgeon held the patient's head at the skull clamp.
 
Manufacturer Narrative
It is evidence through the investigation of the returned unit, that some fluid ingress caused short circuit between the connector and the wires.This resulted in the joints to remain open and not hold in lock position.The ball joint appears to have over heated and damage the ball joint motor.It is unknown if proper cleaning method as instructed in the owner's manual was applied.
 
Event Description
It was reported that 30 to 45 minutes into this case the surgeons noticed that the head of the patient was slowly moving downward.One surgeon had to break scrub to stop it from moving down any further while the other surgeon held the patient's head at the skull clamp.
 
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Brand Name
LEVÓ
Type of Device
HEAD POSITIONING UNIT
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587 1234
MDR Report Key8903051
MDR Text Key183884145
Report Number2921578-2019-00031
Device Sequence Number1
Product Code JEA
UDI-Device Identifier00842430104992
UDI-Public00842430104992
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7887-050
Device Catalogue Number7887-050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Date Manufacturer Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2921578-10/16/2019-001-R
Patient Sequence Number1
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