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	10/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in or 1/labor and delivery, the d660 surgical light disconnected from the cardanic arm.A stryker field service technician (sfst) was dispatched for investigation, and he reported that the root cause of the separation was due to missing cardanic arm hardware.The light was found to be unrepairable, and both the light and the spring arm were deinstalled, as requested by engineering.The service and installation history for the surgical light system were reviewed.The installation database showed that the surgical light system in this or was installed on 31 august 2010.The service ticket database showed that the surgical light system was last serviced by stryker on 19 december 2017 for a reported loss of light control issue.During this inspection, the issue was troubleshot to loose cabling/wiring in the ceiling.The cabling was reconnected, and the issue was resolved.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 over 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 (b)(6).If further information is obtained, a supplemental will be filed.
Event or Problem Description
It was reported that the d660 light head disconnected from arm.There were no reported injuries or adverse consequences and no patient involvement.

• 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: 18196517
• Report Number: 0008010153-2023-00023
• Device Sequence Number: 6554057
• 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): 11/22/2023

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: 10/28/2023
• Initial Report FDA Received Date: 11/22/2023
• 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