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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT DUO; SURGICAL LIGHT
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT DUO; SURGICAL LIGHT Back to Search Results
Model Number 4038210
Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
The account alleges that its technician found a gap on the comfort yoke and flange of a trulight lamp head.The investigation is currently ongoing.A follow-up report will be submitted if new information becomes available.
 
Event Description
A user facility's technician found a gap on the comfort yoke and flange of a trulight surgical light.
 
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Brand Name
TRULIGHT DUO
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
carl-zeiss strasse 7-9
saalfeld, 07318
GM  07318
Manufacturer Contact
steffen ulbrich
carl-zeiss strasse 7-9
saalfeld, 07318
GM   07318
MDR Report Key7155061
MDR Text Key96125400
Report Number9681407-2017-00049
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4038210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2010
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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