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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 NameTRULIGHT
Type of DeviceSURGICAL 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 NumberK102758
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2018
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
Event Location No Information
Date Manufacturer Received02/23/2018
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

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