MAUDE Adverse Event Report: MAQUET SAS VOLISTA; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDVCS209031A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our surgical lights ¿ volista access ii.As it was stated, the keypad was not working as its upper touch glass seal was removed from pcb.According to the photographic evidence, the front of the keypad detached from the pcb.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our surgical lights ¿ volista access ii.As it was stated, the keypad was not working as its upper touch glass seal was removed from pcb.According to the photographic evidence, the front of the keypad detached from the pcb.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.The device has been repaired by replacement of vcs2-400/600- light head keypad w/out tk (ard368876555) and returned to use.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.It is not known if the claimed device was or was not being used for patient treatment or diagnosis when the event took place.According to the analysis by subject matter expert: the vcsii headlight¿s keypad foil detached and dropped.The root cause of the front panel detachment in the capacitive keyboard to the pcb lies in the adhesive choice implemented during the product design stage.A design change (ecr-241203) has been initiated in order to improve the keypad adherence to the pcb.This ecr is not implemented yet and is planned for sep-2025.This topic remains the source of very few incidents, despite everything.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(6).

• Brand Name: VOLISTA
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 20892351
• Report Number: 9710055-2024-0000625
• Device Sequence Number: 18320370
• Product Code: FSY
• UDI-Device Identifier: 03700712420642
• UDI-Public: (01)03700712420642
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARDVCS209031A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown