MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	CH00000001
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in or 17 the d series light disconnected from the spring arm.The cardanic separated from the spring arm and hit a nurse on the shoulder as it fell.This occurred during a procedure but there was no reported injury or adverse consequence to the patient.The nurse reported only bruising at the time and no medical intervention was required.A stryker field service technician (sfst) was dispatched for investigation.During his inspection, the sfst found that four mounting screws which are used to secure the cardanic arm to the surgical light had backed out.The sfst replaced the light head with a new light head and confirmed functionality.The service and installation history for the equipment in or 17 was reviewed.The service ticket database showed service history since april 2008 but there were no reports of maintenance, repairs, or adjustments that required light head maintenance or removal.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 and the service history, the root cause of the separation would be loosening of the cardanic arm hardware due to improper maintenance by hospital personnel.
Event or Problem Description
It was reported a d660 light on an nc suspension fell in operating room 17.The cardanic separated from the spring arm and struck a nurse in the shoulder as it fell.They turned off the power to the suspension and cut the wires to remove it from the area.The nurse reported only bruising at the time and no medical intervention was required.

• 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: 13055979
• Report Number: 0008010153-2021-00009
• Device Sequence Number: 1505995
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/21/2021
• 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