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

Model Number	ARDVCS209004A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: fund inst de molestias do aparelho digestivo e da nutri - hosp prof edmundo (sp) additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 29th december, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the label was missing.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 or serious injury.
Event or Problem Description
On 29th december, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the label was missing.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 or serious injury.Further information provided by getinge employee indicated that missing label was placed outside the sterile area.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 was no possibility of sterile field contamination, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
The initial reporter was engineer.The correction of b5 describe event and problem, h3a device evaluated by manufacturer?, h3b device not eval provide code, h3c if other provide code -explain, h4 manufacture date and h6 investigation finding fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 29th december, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the label was missing.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 or serious injury.Corrected b5 describe event and problem: on 29th december, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the label was missing.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 or serious injury.Further information provided by getinge employee indicated that missing label was placed outside the sterile area.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 was no possibility of sterile field contamination, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h3a device evaluated by manufacturer?: no.Corrected h3a device evaluated by manufacturer?: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code -explain: device not returned to manufacturer.Corrected h3c if other provide code -explain: n/a.Previous h4 manufacture date: 2020-03-23 corrected h4 manufacture date: 2020-03-24 previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: none initially provided information was pointing to missing label.The issue is considered as safety related as any particles falling off into sterile field or during procedure may cause contamination or serious injury.According to additional clarification provided by the getinge technician, the initial information was not clear.It was determined that the issue investigated herein is not safety and risk related as mentioned missing label was placed outside the sterile area, so there was no possibility of sterile filed contamination.The investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• 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: 18434578
• Report Number: 9710055-2024-00006
• Device Sequence Number: 12677697
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: 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): 01/03/2024

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
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown