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

Model Number	ARDVCS209005A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista access 400/400.It was stated, the paint was peeling from arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since paint chipping 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.According to subject matter expert at manufacturer¿s, the most probable root cause of this premature paint degradation would be an incorrect cleaning procedure/ product.All maquet sas products comply with: iec 60601-1ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-1-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection product test: the aim of these tests is to detect any incompatibility with disinfectant.This event is clearly due to the cleaning product.Nevertheless, the deterioration of the paint is far advanced and it must have started years ago.Such troubles should have been detected first by the user during daily and monthly checks.The current cleaning product must be improved as described in the user manual.The damaged parts must be replaced as soon as possible.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 1st october, 2024 getinge became aware of an issue with one of surgical lights - volista access 400/400.It was stated, the paint was peeling from arm.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: 20426132
• Report Number: 9710055-2024-0000557
• Device Sequence Number: 18247838
• Product Code: FSY
• UDI-Device Identifier: 03700712401313
• UDI-Public: (01)03700712401313
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 10/11/2024

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?: No
• Device Model Number: ARDVCS209005A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown