On 27th april, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the spring arm rod was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
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On 27th april 2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the lower elbow of spring arm was broken.The failure was evident during a diagnostic visit.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
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The initial reporter was distributor.The correction of e1b event site name, b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 27th april 2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the spring arm rod was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 27th april 2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the lower elbow of spring arm was broken.The failure was evident during a diagnostic visit.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d4 catalog#: ardvcs209005a, corrected d4 catalog#: none, previous d4 unique identifier (udi)#: n/a, corrected d4 unique identifier (udi)#: (b)(4).Getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the lower elbow of spring arm was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.The device was being used for patient treatment upon the event occurrence.The breakage has probably been caused by an important shock due to the spring arm release when it was in low position and without the light head.The direct consequence of this incident is the breakage of the covers of the spring arm.This incident is due to in improper use of the spring arm during an installation or maintenance procedure.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
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