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The incident occurred on (b)(6) 2021 at 6 pm.During the end of the surgical procedure the perioperative nurse was dressing the patients surgical wound.The nurse anaesthetist (that was affected by the malfunction of the surgical light) was at the head of the patient getting ready to wake the patient from anaesthesia.The surgical light was shining down on the patient.There were no surgical instruments on the patient that could have reflected the light.The nurse anaesthetist got blinded by the surgical light and experienced a sharp pain on the right eye.The nurse anaesthetist proceeded with her shift on tuesday evening/night.On (b)(6) 2021, the nurse anaesthetist experienced vision loss and an occurring shadow on her right eye.On (b)(6) 2021, she sought medical attention due to vision loss on the right eye.She then went through an emergency eye surgery on (b)(6) 2021 due to retinal detachment.Probable cause of the eye injury is due to the newly installed surgical light iled7, hillrom surgical light.No impact to the patient was reported.This report was filed in our complaint handling system as complaint # (b)(4).
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A hospital biomed technician provided information, that the light head involved in this event has a higher illumination rate as all other light heads within the hospital.It was further mentioned the used measuring equipment provides in general too high values.Based on this allegation it was decided to exchange the light head involved in the event for a deeper investigation by the manufacturer.The investigation did not reveal any deviations from the functionality, the technical data or the requirements of the applicable standards.The alleged "higher illumination rate" could not be confirmed.No device problem, malfunction or any other issue with the light head was identified, it was working according to it's specifications.Further, a clinical evaluation was performed for the reported injury.Follow-up with the customer found that the nurse anesthetist was diagnosed with a proximal detachment.It is also noted that the associated nurse is a 55-year-old female with a history of myopia, and continuously wears eyeglasses/ contact lenses.The nurse anesthetist underwent surgical correction for a retinal detachment, the recovery is ongoing and is currently measured at 80% "with a remaining cataract".Additional correctional procedures are planned based on recovery milestones.It is noted that the nurse has since been diagnosed with a vitreous detachment of the left eye in which no medical intervention was reported.The customer stated that the light was shining down, about 2 meters, from the foot of the operating table at a skew angle and a theater nurse changed the angle of the light.At that moment, the nurse anesthetist was moving around, "changed position", and "experienced a razor-sharp pain in the eye." it is noted both the light and the nurse anesthetist were moving around.It is reasonable to conclude that during the movement of the light by the theater nurse, combined with the movement of the nurse anesthetist, the light was inadvertently shined at the nurse anesthetist.It is noted that those involved "did not receive any prior training on the use of the light." additionally, the customer lacked an understanding of use of the light, when asked to provide details related to the light's intensity and shadow management settings the customer stated "we cannot answer this question since we do not know what it is" and "we are in need of training." in the event the light was shined at the nurse anesthetist, the brief encounter is unlikely to result in the reported proximal detachment.Although the reported event can be contributed to the customer's lack of device training, the reported eye injury of proximal detachment is likely due to an underlying health condition, such as myopia which is a risk factor for detachment.Based on the details provided the event can be contributed to possible misuse of the device, however, the injury is likely due to an underlying condition (myopia) and not the use of the light.The report that surgical intervention was required, meets the definition of a serious injury.Therefore, this event is considered reportable due to the serious injury involved.A further training of the hospital staff will be organized.Based on this, no further actions are necessary.
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The incident occurred on (b)(6) 2021 at 6 pm.During the end of the surgical procedure the perioperative nurse was dressing the patients surgical wound.The nurse anaesthetist (that was affected by the malfunction of the surgical light) was at the head of the patient getting ready to wake the patient from anaesthesia.The surgical light was shining down on the patient.There were no surgical instruments on the patient that could have reflected the light.The nurse anaesthetist got blinded by the surgical light and experienced a sharp pain on the right eye.The nurse anaesthetist proceeded with her shift on tuesday evening/night.On (b)(6) 2021, the nurse anaesthetist experienced vision loss and an occurring shadow on her right eye.On (b)(6) 2021, she sought medical attention due to vision loss on the right eye.She then went through an emergency eye surgery on (b)(6) 2021 due to retinal detachment.Probable cause of the eye injury is due to the newly installed surgical light iled7, hillrom surgical light.No impact to the patient was reported.This report was filed in our complaint handling system as complaint#: (b)(4).
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