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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED DUO TUSM; SURGICAL LIGHT
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED DUO TUSM; SURGICAL LIGHT Back to Search Results
Model Number 1565160
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Event Description
It is alleged that the display monitor bracket was dropping down slightly.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The device was checked and it was identified that the moon clip was wore causing the groove it sits in to ramp and let the bracket move down a bit.The bracket and clip were replaced and device functioned as designed.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
 
Manufacturer Narrative
The iled light system was inspected by a field service technician.It was identified that the locking segment (crescent key) wore causing the groove it sits in to ramp and let the bracket move down a bit.Based on our product history records no preventive maintenance is noted.The device is 8 years old and preventative maintenance is required every 2 years.Regarding the maintenance protocol the moon clip needs to be checked and the thickness should be measured.The root cause for the event was traced to not following the instructions for use, missing regularly preventive maintenance.The light system was repaired and checked for functionality.Based on this, no further actions are required.
 
Event Description
It is alleged that the display monitor bracket was dropping down slightly.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand Name
ILED DUO TUSM
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
carl-zeiss-strasse 7-9
saalfeld thuringen 07318
GM  07318
Manufacturer Contact
frances coote
carl-zeiss-strasse 7-9
saalfeld 07318
GM   07318
MDR Report Key15216220
MDR Text Key304718655
Report Number3007143268-2022-00018
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1565160
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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