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

Model Number ARD515050999/ARD567910919

Device Problem Unintended Collision (1429)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 18th april 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated, the stops of the device were not set in correct position which resulted in the device coming into contact with the ceiling and scraping paint off.There was no injury reported, however, we decided to report the issue in abundance of caution as our device contributed to detachment of paint particles from the ceiling and any particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: VOLISTA ACCESS
• 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: 16938212
• MDR Text Key: 315283222
• Report Number: 9710055-2023-00364
• 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: 05/16/2023

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
• Device Model Number: ARD515050999/ARD567910919
• Device Catalogue Number: ARD515050999/ARD567910919
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1