MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG VIDIAPORT CEILING SINGLE; SURGICAL LIGHT

Model Number	4028110
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	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Customer reported the spring arm detached from the central axis but did not fall down.No harm or significant impact to the procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
Customer reported the spring arm detached from the central axis but did not fall down.No harm or significant impact to the procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Incorrect model, serial and udi information provided in final report.Updated report to include correct information.The field service of baxter performed an onsite investigation at the hospital.The failure "spring arm detached" could confirmed during the inspection.The spring arm has slipped approximately 1 inch from the central axis.The technician found that the spring arm's retaining ring had come loose.According to the inspection, the retaining ring was still in good condition and had no defects.No service or maintenance records were found in the product history, other than the reported incident.An installation error or inadequate maintenance of the retaining ring spring arm are the most likely causes.The spring arm was reassembled and the retaining ring checked for correct seating.Based on this, not further actions are necessary.
Event or Problem Description
Customer reported the spring arm detached from the central axis but did not fall down.No harm or significant impact to the procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
The field service of baxter performed an onsite investigation at the hospital.The failure "spring arm detached" could confirmed during the inspection.The spring arm has slipped approximately 1 inch from the central axis.The technician found that the spring arm's retaining ring had come loose.According to the inspection, the retaining ring was still in good condition and had no defects.No service or maintenance records were found in the product history, other than the reported incident.An installation error or inadequate maintenance of the retaining ring spring arm are the most likely causes.The spring arm was reassembled and the retaining ring checked for correct seating.Based on this, not further actions are necessary.

• Brand Name: VIDIAPORT CEILING SINGLE
• 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 ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 20673913
• Report Number: 3007143268-2024-00063
• Device Sequence Number: 8395725
• Product Code: FSY
• UDI-Device Identifier: 00887761968523
• UDI-Public: 00887761968523
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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: 4028110
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 10/23/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/21/2025; 01/22/2025
• 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