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

Model Number ARD568805903

Device Problem Leak/Splash (1354)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

E1b event site name: (b)(6) e1i event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On 5th april, 2024 getinge became aware of an issue with one of surgical lights - volista access 400.It was stated the lubricant was leaking from light arm, oil / grease stain was present at lower dustcover of spring arm towards suspension arm.According to the information provided by getinge technician the issue was caused probably by warmer temperature resulting in excess grease within spring arm to soften accumulate at dustcover.There was no injury reported, however, we decided to report the issue in abundance of caution as any droplets falling off into sterile field or during procedure may cause contamination.

• Brand Name: VOLISTA ACCESS 400
• 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: 19086002
• MDR Text Key: 339878908
• Report Number: 9710055-2024-00258
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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 Operator: Health Professional
• Device Model Number: ARD568805903
• Device Catalogue Number: ARD568805903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1