MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT

Model Number	4068310
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	12/11/2023
Type of Reportable Event	Malfunction
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
It was reported that the light head of the iled 7 surgical light system fell down during a surgical procedure on the back of a surgeon.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
Investigation by baxter medical identified that the locking segment (crescent key), 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 covered 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.During on-site investigation, it was identified this screw was missing.The missing screw allowed the sleeve to move upside.If the sleeve is not in the correct place the crescent key can move out of the connection over time allowing the light head to detach.A review of the past service events showed a preventive maintenance performed by baxter in september 2023.The relevant check point at the maintenance protocol indicated the screw was in place at this time.Based on this no further actions are needed.
Event or Problem Description
It was reported that the light head of the iled 7 surgical light system fell down during a surgical procedure on the back of a surgeon.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ILED 7 CEILING TRIO
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 18364275
• Report Number: 3007143268-2023-00047
• Device Sequence Number: 18066568
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: 887761995840
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/15/2024

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: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/15/2024
• 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