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

Model Number CH00000001

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Bruise/Contusion (1754)

Event Date 12/02/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 284531645
• Report Number: 0008010153-2021-00009
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1