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

Model Number ARD368818998

Device Problem Corroded (1131)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the arms were rusted.There was no injury reported, however, we decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: VOLISTA STANDOP 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: 18947878
• MDR Text Key: 338367121
• Report Number: 9710055-2024-00223
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD368818998
• Device Catalogue Number: ARD368818998
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1