MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS 400 / 400; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDVCS209004A
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 10th november, 2023 getinge became aware of an issue with one of surgical lights - volista access 400/400.Based on photographic evidence the paint was chipping from the suspension arm, and the rust was visible in the place where the paint was missing.We decided to report the issue in abundance of caution as any paint or rust particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The initial reporter was a technician from the hospital.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 10th november, 2023 getinge became aware of an issue with one of surgical lights - volista access 400/400.Based on photographic evidence the paint was chipping from the suspension arm, and the rust was visible in the place where the paint was missing.We decided to report the issue in abundance of caution as any paint or rust particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on 23th november 2023 indicated there were no paint chips and rust on the device, the device was dirty.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there were no paint chips and rust, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 10th november, 2023 getinge became aware of an issue with one of surgical lights - volista access 400/400.Based on photographic evidence the paint was chipping from the suspension arm, and the rust was visible in the place where the paint was missing.We decided to report the issue in abundance of caution as any paint or rust particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 10th november, 2023 getinge became aware of an issue with one of surgical lights - volista access 400/400.Based on photographic evidence the paint was chipping from the suspension arm, and the rust was visible in the place where the paint was missing.We decided to report the issue in abundance of caution as any paint or rust particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on 23th november 2023 indicated there were no paint chips and rust on the device, the device was dirty.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there were no paint chips and rust, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Initial information provided was pointing the paint was chipping from the suspension arm, and the rust was visible in the place where the paint was missing.Paint chipping and external rust based on risk, is considered as a potentially reportable incident, therefore an incident was reported.After performing an evaluation on the customer site the getinge employee informed that were no paint chips and rust on the device, the device was dirty.Therefore the initial information that were considered to be reportable was determined to did not occur.We have performed a root cause evaluation for the dirt issue.The investigated customer product complaint did not cause risk to human life.The source of the raised issue was most likely root cause user error (uue).The complaints did not cause any risk to human life.Following information from the user manual (e.G.Powerled ii ifu 01811 en 09 pages 97-100), user can allow the device to function properly.Comparing number of the received customer product complaints for dirty devices which occurred on surgical lights investigated herein, to their install bases, failure ratio is very low.After reviewing the information provided for the complaints investigated here, complaint handler did not identify any apparent reason for suggesting to open capa or evaluation for the need of an action in the market.It is not likely that it could lead to the serious injury or death when the issues were to reoccurs.That is why it is not considered to be safety related and reportable.

• Brand Name: VOLISTA ACCESS 400 / 400
• 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: 18157492
• Report Number: 9710055-2023-00891
• Device Sequence Number: 20473089
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: (01)03700712401320
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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
• Operator of Device: Other
• Device Model Number: ARDVCS209004A
• Device Catalogue Number: ARDVCS209004A
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown