Model Number ARD568811911 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/20/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
|
|
Event Description
|
On 20th april, 2022 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated that cover was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
|
|
Manufacturer Narrative
|
Getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated that dust cover and spring arm cover were missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.According to the service report provided by the getinge technician, both of the missing cover were replaced and the affected device is fully operational and ready to use.It was established that when the event occurred, the surgical light did not meet its specification due to missing covers and as a result, it contributed to the event.Provided information do not indicate if upon the event occurrence, the device was or was not being used for patient treatment.Review of received customer product complaints related to investigated issues, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to the number of devices sold worldwide, we can assume that the failure ratio of missing covers from volista surgical lights is very low.As stated by subject matter expert the metal spring arm¿s metal cover (dust cover) comes out and can fell off the device.Performed investigation allowed to distinguish possible root causes for this malfunction: non-conformity of the metal covers assembly.Degradation of the metal covers.Improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation would have been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.The correction of b5 describe event or problem fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 20th april, 2022 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated that cover was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 20th april, 2022 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated that dust cover and spring arm cover were missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
|
|
Event Description
|
On 20th april, 2022 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated that dust cover and spring arm cover were missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
|
|
Manufacturer Narrative
|
According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.
|
|
Event Description
|
Manufacturer reference number (b)(4).
|
|
Search Alerts/Recalls
|