MAUDE Adverse Event Report: BERCHTOLD GmbH & Co. KG CHROMOPHARE; light, surgical, ceiling mounted

Catalog Number	CH00000001
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	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cosmetic cover of the slx surgical light system shifted downward.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: CHROMOPHARE
• Common Device Name: light, surgical, ceiling mounted
• Manufacturer (Section D): BERCHTOLD GmbH & Co. KG; ludwigstaler straße 25; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GmbH & Co. KG; ludwigstaler straße 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: arsalan rizvi ; ludwigstaler straße 25; tuttlingen 78532 ; GM 78532 ; +49()74611810
• MDR Report Key: 50488632
• Report Number: 0008010153-2026-00010
• Device Sequence Number: 13315476
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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
• Operator of Device: Other
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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