MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT

Model Number	4068310
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged the light head was dropped.The bio med went to secure the light head to the spring arm and it fell to the floor.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
Inspection of the device is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
The customer alleged the light head was dropped.The bio med went to secure the light head to the spring arm and it fell to the floor.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
During follow-up with the customer it was identified the light head fell during the maintenance procedure carried out by the hospital biomed.For maintenance it is required to remove the light head from the support arm system.During this, the light head fell based on a handling failure of the technician.There was no impact to a surgical procedure and no identified device malfunction.Mthe defect light head will be replaced.Based on this, not further actions are required.

• Brand Name: ILED 7 CEILING TRIO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• Manufacturer Contact: frances coote ; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 15518513
• Report Number: 9681407-2022-00023
• Device Sequence Number: 16770845
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: 887761995840
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown