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	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that light 1 in or 7 has separated from the suspension and fallen to the ground.The connection to the spring arm still present on the suspension and the lc bearing has broken and slid out of the proximal end of the cardanic.There was one employee and no patients in the room when this happened.No one was struck by the falling light.Prior to this event the light did not have control from the cfwp, but would turn on from the light head.There were no reported injuries or adverse consequences.
Event or Problem Description
It was reported that light 1 in or 7 has separated from the suspension and fallen to the ground.The connection to the spring arm still present on the suspension and the lc bearing has broken and slid out of the proximal end of the cardanic.There was one employee and no patients in the room when this happened.No one was struck by the falling light.Prior to this event the light did not have control from the cfwp, but would turn on from the light head.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported that light 1 in or 7 has separated from the suspension and fallen to the ground.It was reported that the connection to the spring arm was still present on the suspension and the lc bearing has broken and slid out of the proximal end of the cardanic.There was one employee and no patients in the room when this happened.No one was struck by the falling light.Prior to this event the light did not have control from the cfwp, but would turn on from the light head.There were no reported injuries or adverse consequences.Field service technician visited facility and found that the cardanic dog screw was worn and damaged the cardanic.Both needed to be replaced.A new spring arm and cardanic were replaced, keeping the same light head and put back into service (fully functional).The product was not returned for investigation.There have been no reported issues since the equipment was replaced and light head put back into service.Although the exact root cause of this issue is unknown, the most likely root cause would be related to improper preventative maintenance.As was reported, there was one employee and no patients in the room when this happened, and there was no patient involvement or adverse event reported.This failure mode has not exceeded any thresholds and will continue to be monitored.If any further information is received, a supplemental will be filed.

• 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: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18899400
• Report Number: 0008010153-2024-00005
• Device Sequence Number: 15413828
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/04/2024

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
• Operator of Device: Other
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/04/2024
• 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