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

Model Number	ARDVCS209016A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1b event site name: (b)(6) e1i event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 5th april, 2024 getinge became aware of an issue with one of surgical lights - volista access 400.It was stated the lubricant was leaking from light arm, oil / grease stain was present at lower dustcover of spring arm towards suspension arm.According to the information provided by getinge technician the issue was caused probably by warmer temperature resulting in excess grease within spring arm to soften accumulate at dustcover.There was no injury reported, however, we decided to report the issue in abundance of caution as any droplets falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista access 400.It was stated the lubricant was leaking from light arm, oil / grease stain was present at lower dust cover of spring arm towards suspension arm.According to the information provided by getinge technician the issue was caused probably by warmer temperature resulting in excess grease within spring arm to soften accumulate at dustcover.There was no injury reported, however, we decided to report the issue in abundance of caution as any droplets 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 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.As stated by the subject matter expert at the manufacturer¿s site, during the assembly of spring arms the supplier applies a creamed grease.Such creamed grease is turning into liquid only above 135°c.So, the black dripping liquid observed, therefore, cannot come from the spring arm itself but finds its origin elsewhere.The first likely cause is a combination of air conditioning and an excess of oil at the bushing location between the spring arm and the main arm.And according to the latest technical investigations carried out in august 2020 at maquet sas the second probable root cause would be an excess of cleaning product in the lower part of the spring arm, applied in spray or with a sponge, but not in compliance with the recommendations given in our user manual.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.The correction of d4 catalog # and unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d4 catalog # ard568805903.Corrected d4 catalog # blank.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).The correction of d1 brand name deems required.This is based on the internal evaluation.Previous d1 brand name volista access 400.Corrected d1 brand name volista.
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: 19086002
• Report Number: 9710055-2024-00258
• Device Sequence Number: 12566793
• Product Code: FSY
• UDI-Device Identifier: 03700712420482
• UDI-Public: (01)03700712420482
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARDVCS209016A
• Device Catalogue Number: ARD568805903
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown