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

Model Number	ARDVCS209018A
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	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 6th november, 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated the ceiling cover was falling down.The technician stated that after fixing the ceiling cover, it was tested to see if it would naturally come down due to its own weight, but it did not come down.Then, it was checked if the cover had lowered due to contact with an arm, etc., but there were no noticeable collision marks, so it is unlikely that this was the cause of the lowering.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.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 version of model # and d4 catalog # and d4 serial # and h4 manufacture date, d4 unique identifier (udi), h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous d1 brand name: volista access corrected d1 brand name: volista, previous d4 version of model # ard568806906, corrected d4 version of model # ardvcs209018a, previous d4 catalog # ard568806906, corrected d4 catalog # none, previous d4 serial #(b)(6), corrected d4 serial # (b)(6), previous d4 unique identifier (udi) #: n/a, corrected d4 unique identifier (udi) #: (b)(4), previous h4 manufacture date: 2023-05-31, corrected h4 manufacture date: 2022-08-19, previous h3a device evaluated by manufacturer: no, corrected h3a device evaluated by manufacturer: yes, previous h3b device not eval provide code: other, corrected h3b device not eval provide code: n/a, previous h3c if other provide code - explain: device not returned to manufacturer, corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated the ceiling cover was falling down.The technician stated that after fixing the ceiling cover, it was tested to see if it would naturally come down due to its own weight, but it did not come down.Then, it was checked if the cover had lowered due to contact with an arm, etc., but there were no noticeable collision marks, so it is unlikely that this was the cause of the lowering.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.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: it was reported that the ceiling cover started to fall down.By design the sealing rubber assembled on the tube, under the cover, holds the cover in place.According to the information provided, the technician checked to see if the rubber was loose, but it was tightly tightened and did not come down.After fixing the ceiling cover, he tested to see if it would naturally come down due to its own weight, but it did not come down.The cause of the sealing rubber displacement could not be determined.The cover was fixed again while it was in contact with the ceiling and confirmed that it did not move.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)(4).

• 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: 18197964
• Report Number: 9710055-2023-00907
• Device Sequence Number: 15290140
• Product Code: FSY
• UDI-Device Identifier: 03700712420505
• UDI-Public: (01)03700712420505
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: ARDVCS209018A
• Device Catalogue Number: ARD568806906
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/23/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown