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

Model Number	ARDVCS209002A
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	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was getinge biomechanical engineer.; e1b event site name: (b)(6); additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 13th september,2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated that one of the suspension bushing fixing screws fell off from the spring arm.According to the information provided by getinge technician another screw was installed instead of the fallen screw due to the risk of the lighthead falling.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 or serious injury.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista access.It was stated that one of the suspension bushing fixing screws fell off from the spring arm.According to the information provided by getinge technician another screw was installed instead of the fallen screw due to the risk of the lighthead falling.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 or serious injury.Missing parts vlt access - 4 preglued screws fhc m6x16 (ard368835555) were replaced and device was back to usage.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 device was or was 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 stated that one of the suspension bushing fixing screws fell off from the suspension (and not the spring arm).The customer's suspension was manufactured in 2018.After investigation, these pre-glued screws have been applied since 17 february 2017 in production for all sb suspensions (following the internal document "(b)(4).C").The pre-glued of these screws acts as a mechanical locking and prevents the loosening and the fall of the screw.The screw have a threading, its loosening is visually detectable during cleaning or during yearly preventive maintenance.The most probable root cause: the screw was not tightened during the installation or a maintenance/repair.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: VOLISTA ACCESS
• 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: 20341760
• Report Number: 9710055-2024-0000539
• Device Sequence Number: 18094033
• Product Code: FSY
• UDI-Device Identifier: 03700712401344
• UDI-Public: (01)03700712401344
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: ARDVCS209002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown