MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 1000 / PENDANT; SURGICAL LIGHT

Model Number	4058140
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A repair was ordered and further investigation is ongoing.
Event or Problem Description
It was alleged the trulight light head and spring arm detached and fell from the ceiling.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 investigation it was identified one washer was missing at the connection between spring arm and central axis.This must have caused additional wear at the snap ring which secures the spring arm to the central axis.The cause for the missing washer could not be concluded.It was maybe missing from the initial installation in 2012 or was removed at a service event.The device history did not show any service activity or maintenance carried out by hillrom.According to the ifu the device must be maintained regularly by an authorized and train individual.Based on this no further action is required.
Event or Problem Description
It was alleged the trulight light head and spring arm detached and fell from the ceiling.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT 1000 / PENDANT
• 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: steffen ulbrich ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 14337430
• Report Number: 9681407-2022-00007
• Device Sequence Number: 6323196
• Product Code: FSY
• UDI-Device Identifier: 00887761986114
• UDI-Public: 887761986114
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: 4058140
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 09/13/2022
• 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