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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT; SURGICAL LIGHT
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT; SURGICAL LIGHT Back to Search Results
Model Number 4038310
Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Issue (2379)
Patient Problem Injury (2348)
Event Date 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
A trumpf medical authorized technician was dispatched and replaced the affected side handle end cap.The investigation is currently ongoing.A follow-up report will be submitted once new information becomes available.
 
Event Description
The side handle end cap of a trulight light head fell off during a surgery and hit the patient.No injury occurred.
 
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Brand Name
TRULIGHT
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 Key7361318
MDR Text Key103556140
Report Number9681407-2018-00013
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K102758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Remedial Action Repair
Type of Report Initial
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4038310
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/23/2018
Initial Date FDA Received03/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2017
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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