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

Model Number	ARD568852911/ARD568851911
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On 22nd november, 2022 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated, the paint was flaking off from the handle.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
The correction of b5 describe event and problem, d4 version or model #, d4 catalog #, d4 serial #, h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 22nd november, 2022 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated, the paint was flaking off from the handle.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.Corrected b5 describe event and problem: on 22nd november, 2022 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400/600.As it was stated, the paint was flaking off from the handle and corrosion has built up on the spring arm.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.Previous d4 version or model # ard568852911.Corrected d4 version or model # ard568852911/ard568851911.Previous d4 catalog # ard568852911.Corrected d4 catalog # ard568852911/ard568851911.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous h3a device evaluated by mfg: no.Corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: none.Previous h3c if other provide code-explain: device not returned to manufacturer.Corrected h3c if other provide code-explain: none.Getinge became aware of an issue with one of our surgical lights ¿ volista standop 400/600.As it was stated, the paint was flaking off from the handle and corrosion has built up on the spring arm.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 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.A technical evaluation of rust was performed by subject matter experts who stated that: 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.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions (see user manuals or ifu), 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 appareance of rust or the degradation of the surface, the technical manual or maintenance manuals mentions in the preventive maintenance to lubricate some parts of device.To prevent any incident the user manuals 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.The most probable root cause of this paint delamination would be an oxidation surface before painting.Nevertheless, the painter doesn¿t explain this phenomenon but will be very attentive in the future regarding the surface quality before painting.The painting process supplied by the supplier is detailed explaining each step from degreasing to adhesion tests.This defective handle was painted in 2020.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 22nd november, 2022 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400/600.As it was stated, the paint was flaking off from the handle and corrosion has built up on the spring arm.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.

• 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: 15863764
• Report Number: 9710055-2022-00490
• Device Sequence Number: 12257629
• Product Code: FSY
• UDI-Device Identifier: 03700712401689
• UDI-Public: (01)03700712401689
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/24/2022

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: ARD568852911/ARD568851911
• Device Catalogue Number: ARD568852911/ARD568851911
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 11/24/2022
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown