MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 600; LAMP, SURGICAL

Model Number VOLISTA STANDOP 600

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated that handle with camera detached from headlight.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

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

The new obtained information is occupation of initial reporter: the surgical area supervisor.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).

Manufacturer Narrative

Getinge became aware of an issue with one of the surgical lights - volista standop.It was stated that the handle with the camera detached from the headlight.We decided to report the issue in abundance of caution as any parts falling off into a sterile field or during a procedure may cause contamination.Based on the information collected, it was established that when the event occurred, surgical light did not meet its specification, since the detachment of the handle with the camera could be considered as a technical deficiency, and in this way the device contributed to the event.There is no information if the device was or was not being used for a patient¿s treatment upon the event occurrence.When reviewing reportable events for these types of issues we were able to establish that the failure ratio of the investigated issue is very low.We have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.A root cause analysis was performed by the subject matter expert.According to the information collected, the camera was inspected.The technician mentioned that the camera is not working and that it has suffered a shock.There is no indication that the locking system (camera/dome) is broken or defective.The customer does not provide information about who handled the product or when they dropped it.The user manual volista standop (01781 rev.16, pages 66-69) describes how to install a camera with a quick lock mechanism to ensure that the quick lock device is correctly in place on the lighthead.To prevent any incident the user manual volista standop (01781 rev.16, pages 38-42) mentions: "check the lightheads for chipped paint, impact marks and any other damage." during the daily check before use.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendations had been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: VOLISTA STANDOP 600
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14110718
• MDR Text Key: 289255735
• Report Number: 9710055-2022-00121
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VOLISTA STANDOP 600
• Device Catalogue Number: ARD568821962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1