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

Model Number	4068210
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	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation is ongoing, results will be provided within a final report.
Event or Problem Description
The customer alleged that during a surgical procedure the light head detached from the spring arm and fell onto a patient.It was further stated the surgeon caught the light.No harm was reported in relation to the event.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
The investigation by hillrom/trumpf medical identified that the locking segment, which secures the light head to the spring arm, came out of the connection.This allowed the light head to separate from the spring arm and fell down.The locking segment is secured by a sleeve to avoid the locking segment to come out.The sleeve is secured by a screw which prevents the sleeve to move from its securing location.In this case the most likely cause is an installation failure of the device, the screw was not installed.Over time the sleeve moved from its position and the locking segment was able to move out.The light head was re-installed an the device is functioning as designed.Based on this, no further actions are required.
Event or Problem Description
The customer alleged that during a surgical procedure the light head detached from the spring arm and fell onto a patient.It was further stated the surgeon caught the light.No harm was reported in relation to the event.This report was filed in our complaint handling system as complaint#: (b)(4).

• Brand Name: ILED 7 CEILING DUO
• 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: 13237563
• Report Number: 9681407-2022-00001
• Device Sequence Number: 4599044
• Product Code: FSY
• UDI-Device Identifier: 00887761995857
• UDI-Public: 887761995857
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/23/2022

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: 4068210
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/24/2022
• 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