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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUVIDIA/VIDAPORT DUO SURGICAL LIGHT

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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUVIDIA/VIDAPORT DUO SURGICAL LIGHT Back to Search Results
Model Number 4028210
Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2018
Event Type  Malfunction  
Manufacturer Narrative

Initial analysis of the handle adapter found that locking pin was not working correctly. The locking pin was exchanged, the spring was adjusted, and the handle adapter worked properly.

 
Event Description

When moving the light head, the sterile handle & adapter fell onto the back of the surgeon. No injury occurred.

 
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Brand NameTRUVIDIA/VIDAPORT DUO
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 Key7517755
MDR Text Key108614246
Report Number9681407-2018-00025
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeLU
PMA/PMN NumberK061317
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,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4028210
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 Received04/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2008
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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