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

Model Number	ARDVCS209007A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (b)(6).Initial reporter was coordinator.Getinge became aware of an issue with one of surgical light ¿ volista access.It was discovered, that the paint degradation occurred on fork.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.According to subject matter expert at manufacturer¿s, the concentration of chemical products and the stagnation of cleaning agent residues on the disinfected surfaces are the main factors leading to the deterioration of surfaces.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since paint peeling could be considered as technical deficiencies, 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.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions , avoiding spraying, high concentrations, prolonged exposure to detergents/disinfectants solutions, and to wipe with a dry cloth and to make sure that no liquid residue is left on the device after cleaning.To reduce the appearance of rust or the degradation of the surface, the technical manual or maintenance manuals mention in the preventive maintenance to lubricate some parts of device.To prevent any incident, the user manual mention to perform daily inspections in order to detect paint defects, impact marks or other damages.Maquet sas recommends to perform corrective maintenance to rectify the default after its detection.Minor paint chips can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.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
On 22th july, 2024 getinge became aware of an issue with one of surgical lights - volista access 400.It was stated and confirmed by photographic evidence the paint was peeling from the fork.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

• 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: 19937627
• Report Number: 9710055-2024-00465
• Device Sequence Number: 11980813
• Product Code: FSY
• UDI-Device Identifier: 03700712401351
• UDI-Public: (01)03700712401351
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 08/08/2024

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
• Device Model Number: ARDVCS209007A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown