It was reported that in wpor 1, the chromophare d650 surgical light caused a patient burn.Through further investigation the stryker field service technician (sfst) reported there were actually two chromophare d660 halogen surgical lights that burned a 3 month old who was undergoing an anorectoplasty procedure.When the sfst went to the site and inspected the surgical lights.During the functional testing it was found that the lights were operating properly.The lux readings were measured, and both lights were found to be operating within specification.It is unknown exactly how close the lights were in proximity to the patient at the time the incident occurred, and there was no reported malfunction of the lights.The cautions and warnings regarding usage of the chromophare d660 halogen surgical lights is located in the berchtold chromophare d660, d540, d510 service manual, part #57184, revision c.Section 2.2.The safety information contained in this section warns against using the lights at distances closer than 60 centimeters.Although the exact root cause of this issue is unknown, potential root causes could include lights being used closer to the patient than prescribed in the chromophare d660 service manual, lights being used in tandem, other surgical tools and equipment being used at the time of the procedure, and operator error.
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There has been corrected data updates made to the following fields: outcomes attributed to ae, clinical signs code grid, health impact code grid, and component code grid.
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