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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MTS; OPERATING TABLE
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MIZUHO ORTHOPEDIC SYSTEMS, INC. MTS; OPERATING TABLE Back to Search Results
Model Number 5943
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Burn(s) (1757)
Event Date 05/18/2016
Event Type  No Answer Provided  
Event Description
Abdomen burn mark on patient after 6-8 hour lumbar fusion, approximately the size of a quarter.Multiple minor burn mark by where the nerve monitoring needles were placed as well as the posterior shoulder.
 
Manufacturer Narrative
The patient's abdomen did come in contact with the rail with no additional padding in-between the patient and the rail.The customer described the wound as being a third degree burn in nature vs a typical pressure wound on the patient's abdomen where it touched the rail.She also indicated that there was nerve monitoring being used, though not around the area that was burned.The point of injury was north of the hip/thigh pads so it was not related to the pressure on the pads.Larger patients may require additional padding around the table's surface in order to reduce pressure issues from occurring.In this instance, the account manager explained that the surgeon using the tale like to laterally tilt it to more extremes.This may be putting additional pressure on the patient at the point of contact.Depending on other patient conditions, this may have varying effects, some of which may be pressure points.Ongoing monitoring of the patient and additional padding to ensure that there is not excess pressure on any sensitive areas is still needed.The account manager has worked with the customer to discuss additional padding options such as gel or foam.The hospital has proactively added further padding to their patient positioning protocol with not further incidents to report.
 
Event Description
Abdomen burn mark on patient after 6-8 hour lumbar fusion, approximately the size of a quarter.Multiple minor burn mark by where the nerve monitoring needles were placed as well as the posterior shoulder.
 
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Brand Name
MTS
Type of Device
OPERATING TABLE
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587 1234
Manufacturer (Section G)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587 1234
Manufacturer Contact
anne leblanc
30031 ahern avenue
union city, CA 94587-1234
5104291500
MDR Report Key5677554
MDR Text Key45853747
Report Number2921578-2016-00010
Device Sequence Number1
Product Code JEA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5943
Device Catalogue Number5943
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2016
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
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight91
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