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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 Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problems Laceration(s) (1946); Concussion (2192)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
A trumpf medical/hillrom service representative inspected the device and identified a defect spring arm.The spring arm was exchanged and will be investigated by trumpf medical/hillrom.The operating light system was repaired and is now working as intended.No further information is available at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
The customer reported that a light head dropped down and hit a user at the head.According to initial information, the user received a laceration on the head and a mild concussion.With the current information provided by the customer, the injury is not considered as an unanticipated serious deterioration in state of health.This report was filed in our complaint handling system as complaint (b)(4).
 
Manufacturer Narrative
The customer reported that a light head dropped down and hit a user on the head.According to the initial information received from the customer, the user sustained a laceration on the head and a mild concussion.Further requests for confirmation of the injuries were made, however this information was not received until 20-nov-2020 (date of initial mdr).With the current information provided regarding the injury, hillrom does not considered the reported injury as an unanticipated serious deterioration in state of health.Trumpf medical/hillrom investigated the device in question (operating light system and especially the spring arm) with the following findings: - the spring tension was adjusted to 13,5 kg (the light head has a weight of 17,6 kg).- the height limit (height stop) was loose and over-torqued by massive force.This would not lead to a sudden drop as originally alleged.However, this shows that an attempt was apparently made to make adjustments to the spring arm which were not successfully.After a further discussion with the responsible commissioner for medical device safety, it could not be confirmed that the originally alleged event has occurred.It is believed the user hit her head on the light head which was located at the same height as the user.The hazardous situation and potential severity of harm from the original allegation could not be confirmed.The review of the relevant risk assessment revealed an exposure to moderate impact force as the highest level of harm.This is not associated with a death or a serious deterioration in the state of health of a patient, user or third person.Therefore, it is concluded that the event does not meet the criteria of a reportable event per 21 cfr 803.The operating light system was repaired by exchanging the spring arm and the device is now working as intended.
 
Event Description
The customer reported that a light head dropped down and hit a user at the head.According to initial information, the user received a laceration on the head and a mild concussion.With the current information provided by the customer, the injury is not considered as an unanticipated serious deterioration in state of health.This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand Name
ILED DUO
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
7-9 carl zeiss strasse
saalfeld 07318
GM  07318
MDR Report Key10894953
MDR Text Key219552810
Report Number9681407-2020-00062
Device Sequence Number1
Product Code FSY
UDI-Device Identifier00887761995956
UDI-Public887761995956
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4028210
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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