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

Model Number	4028310
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	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the cleaning of the surgical room the light head iled detached from the spring arm and fell off.The cresent key came out (this allowed the light head to detach).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.
Additional Manufacturer Narrative
The iled light was inspected by a field service technician.The investigation identified that the light head fell off as there was incorrectly assembly of the retaining segment during the maintenance by our service partner (b)(4).The sleeve was not secured with the screw.No injuries were reported in relation to this allegation.The root cause for the event was traced to incorrect re-assembly during maintenance.Based on this, no further actions are required.
Event or Problem Description
It was reported that during the cleaning of the surgical room the light head iled detached from the spring arm and fell off.The cresent key came out (this allowed the light head to detach).This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VIDIAPORT CEILING TRIO
• Common Device Name: 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 thuringen 07318 ; GM 07318
• MDR Report Key: 15390813
• Report Number: 3007143268-2022-00026
• Device Sequence Number: 5183432
• Product Code: FSY
• UDI-Device Identifier: 00887761995949
• UDI-Public: 887761995949
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 4028310
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/28/2022
• 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