MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; 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	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the or lights came completely off the arm.The light fell after a case while the light was being cleaned.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported that in or 15, the d650 plus surgical light came completely off the arm.A stryker field service technician (sfst) was dispatched for investigation, and he reported that both the light head and the spring arm were damaged beyond repair.Onsite investigation photos were provided that showed that the fasteners used to connect the cardanic arm to the light had backed out, causing the light to separate and fall.Both the light and the spring arm were replaced with spare parts taken from a different or.The service and installation history for the surgical light system were reviewed.The service ticket database showed that the light was last serviced by stryker via a preventive maintenance inspection that was completed on 8 july 2022.Reference case (b)(4) for details.During this inspection, the light was found to be operating properly, and there were no issues noted.The d series lights were sold between 1995 and 2009 and are no longer supported as units have exceeded their lifetime.This light has been in use for at least 10 years.Based on the physical evidence, the root cause of the separation would be damage to the cardanic/light head joint due to a loosening of the hardware used to attach the cardanic arm to the surgical light.This issue was discovered outside of procedure, and there was no reported injury or adverse event.This failure mode will continue to be monitored per dwi2003.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• 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: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 17672983
• Report Number: 0008010153-2023-00016
• Device Sequence Number: 14966690
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 09/01/2023
• 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