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U.S. Department of Health and Human Services

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

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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 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 Consequences Or Impact To Patient (2199)
Event Date 04/03/2018
Event Type  Malfunction  
Manufacturer Narrative

A trumpf medical authorized technician was dispatched and replaced the affected components. Initial analysis found that it was possible to unlock the handle adapter without pressing the locking pin. Exchange parts have been returned for further analysis. The investigation is currently ongoing. A follow-up report will be submitted if new information becomes available.

 
Event Description

The sterile handle adapter (including the sterile handle) fell into the sterile field. No injury occurred.

 
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Brand NameILED 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 Key7480579
MDR Text Key107350058
Report Number9681407-2018-00021
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeBE
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,Followup
Report Date 04/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/02/2018
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 Received04/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2016
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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