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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED Back to Search Results
Model Number TS7500
Device Problems Mechanical Problem (1384); Device Issue (2379); Material Twisted/Bent (2981)
Patient Problem No Information (3190)
Event Date 06/10/2016
Event Type  malfunction  
Event Description
During the surgery the table top did not work anymore.No functions were available and the table top could not be removed from the column.No injury occurred.The root cause was found in a squeezed cable inside an electrical component.The device was repaired.Further investigations are ongoing to determine the root cause of the cable squeeze.
 
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Brand Name
TRUSYSTEM
Type of Device
TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
carl-zeiss strasse 7-9
07318 saalfeld,
GM 
Manufacturer Contact
karen campbell
1046 legrand blvd
charleston, SC 29492
8434161361
MDR Report Key5775416
MDR Text Key49771503
Report Number3007143268-2016-00003
Device Sequence Number1
Product Code JEA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTS7500
Device Catalogue Number1909796
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received06/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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