MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS 600; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568805908

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access 600.It was stated the spring arm rear cover part was broken and has came off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

E1b event site name: (b)(6) hospital e1c event site address: (b)(6).The correction of b5 describe event and problem, e1b event site name, e1c event site address, e1e event site city, h3a device evaluated by manufacturer?, h3b device not eval provide code, h3c if other provide code -explain, h6 medical device ¿ problem code and h6 investigation findings fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access 600.It was stated the spring arm rear cover part was broken and has came off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access 600.It was stated the spring arm rear cover part was broken and has came off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Further information provided by getinge technician employee indicated that the cover has been removed from the arm.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 indication of possible contamination by the cover falling off into sterile field or during procedure, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous e1b event site name: (b)(6).Corrected e1b event site name: (b)(6) hospital.Previous e1c event site address: sekerpinar mh fevzi.Corrected e1c event site address: (b)(6).Previous e1e event site city: (b)(6).Corrected e1e event site city: (b)(6).Previous h3a device evaluated by manufacturer?: no (attach page to explain why not or provide code).Corrected h3a device evaluated by manufacturer?: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: blank.Previous h3c if other provide code -explain: device not returned to manufacturer.Corrected h3c if other provide code -explain: blank.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.Material integrity problem|break||1069.Corrected h6 medical device ¿ problem code: material integrity problem|break||1069.Previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: none.Initially provided information was pointing to cover detachment.The issue is considered as safety related as any particles falling off into sterile field or during procedure may cause contamination.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 there was no indication of possible contamination by the cover falling off into sterile field or during procedure.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.

Event Description

On 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access 600.It was stated the spring arm rear cover part was broken and has came off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Further information provided by getinge technician employee indicated that the cover has been removed from the arm.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 indication of possible contamination by the cover falling off into sterile field or during procedure, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: VOLISTA ACCESS 600
• Type of Device: 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: 18612359
• MDR Text Key: 334181425
• Report Number: 9710055-2024-00101
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568805908
• Device Catalogue Number: ARD568805908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1