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

Model Number	ARDVST229037A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 17th february 2023 getinge became aware of an issue with one of our surgical lights ¿ volista standop.According to photographic evidence, paint was peeling from suspension arms and corrosion has built up on main tube and suspension arms.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device evaluated by mfr: device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d4 catalog # and d4 serial # deems required.This is based on the internal evaluation.Previous d4 catalog # ard567910990.Corrected d4 catalog # ardvst229037a.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Getinge became aware of an issue with one of our surgical lights ¿ volista standop.According to photographic evidence, paint was peeling from suspension arms and corrosion has built up on main tube and suspension arms.There was no injury reported, however, 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 light did not meet its specification due to rust occurrence and paint peeling.Such a scenario could be considered as technical deficiency, and in this way the device contributed to the event.There is no information if the device was or was not being used for a patient¿s treatment upon the event occurrence.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at a low ratio.We have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.The following technical evaluation was performed by subject matter experts at the manufacturing site; for the paint peeling issue, as documented under factory investigation report 2022-225-a.The photographic evidence shows rust formation and paint peeling on the device.It can be observed that the degradation of the paint and corrosion are mostly localized on the retention areas which shows that the stagnation of liquid or cleaning agent residues have caused paint damages and appearance of rust.Peeling paint and rust formation were probably caused by : a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol.The presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use, the relative humidity must be between 20% and 75% (nu ifu 01781 en 19, page 29).To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages (nu ifu 01781 en 19, pages 37, 93).The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning (nu ifu 01781 en 19, pages 89-90).For the rust occurrence, the most probable root cause would be an incorrect operation handling before painting.The pre-treatment operation could be involved.The improper protection after rust or incompletely dry after rust process would have led to the containment and oxidization under the paint.So far, all the cases reported correspond to main arms manufactured before july 2016, hence by the supplier (b)(4).The painting suppliers have changed since (b)(6) 2016.The current one is huaya who has strengthened the process and parameters stability.No cases have been reported since the supplier (b)(4) has been replaced.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: VOLISTA STANDOP
• 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: 16407708
• Report Number: 9710055-2023-00113
• Device Sequence Number: 5758929
• Product Code: FSY
• UDI-Device Identifier: 03700712401719
• UDI-Public: (01)03700712401719
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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
• Device Model Number: ARDVST229037A
• Device Catalogue Number: ARDVST229037A
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown