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

Model Number	ARDVCS209000A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 3rd august 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400/400.According to the photographic evidence, the paint was peeling from fork.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.Event site name (e1): (b)(6).H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, d4 catalog #, version or model #, serial # and h4 manufacture date deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 3rd august 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400/400.According to the photographic evidence, the paint was peeling from fork.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 3rd august 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400/400.According to the photographic evidence, the paint was peeling from fork as well as there was label chipping off.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 catalog # ard515071899.Corrected d4 catalog # ardvcs209000a.Previous d4 version or model # ard515071899.Corrected d4 catalog # ardvcs209000a.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous h4 manufacture date: 2017-05-31.Corrected h4 manufacture date: 2017-11-03.Getinge became aware of an issue with one of our surgical lights ¿ volista access 400/400.According to the photographic evidence, the paint was peeling from fork as well as there was label chipping off.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 paint peeling and label chipping off.Such a scenario could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence the device was or was not being used for patient treatment, however there was no harm to patient's health.When reviewing similar reportable events it was confirmed that there was no serious injury or worse reported due to paint peeling and label chipping off on volista in the last 5 years.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of paint peeling is moderate and low for label chipping off.A technical evaluation of paint chipping root cause was performed by subject matter experts at the manufacturing site and documented under factory investigation report 2018-087-b.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 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 products test: the aim of these tests is to detect any incompatibility with disinfectant.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced (user manual ifu 01781 en 16, pages 38-39).Regarding the issue with the chipped label, as stated by the subject matter expert, the most probable root cause is an excessive friction during cleaning or inappropriate cleaning products.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendations 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.
Event or Problem Description
On 3rd august 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400/400.According to the photographic evidence, the paint was peeling from fork as well as there was label chipping off.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 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: 17479012
• Report Number: 9710055-2023-00577
• Device Sequence Number: 2686703
• Product Code: FSY
• UDI-Device Identifier: 03700712400507
• UDI-Public: (01)03700712400507
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: ARDVCS209000A
• Device Catalogue Number: ARDVCS209000A
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown