MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 400; LAMP, SURGICAL

Model Number ARD568852963

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Skin Tears (2516)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The initial reporter was the clinical engineering team.H3 other text : device not returned to manufacturer.

Event Description

On 22nd september, 2023 getinge became aware of an issue with one of surgical lights - volista standop 400.According to the customer allegation during the operator's handling of the surgical procedure, the dome hit an air filter in the false ceiling of the operating room, causing it to fall on the surgeon's head.The air filter was hit because the height of the spring arm was not correctly adjusted.Medical intervention was required on the surgeon who was affected.The surgeon received 4 stitches for a cut to his head.Spring arm height adjustment of both domes was performed, repair was completed, the arm movement tests carried out with positive results.The outcome as described is consider to meet the definition of a serious injury.

• Brand Name: VOLISTA STANDOP 400
• Type of Device: LAMP, SURGICAL
• 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: 17860598
• MDR Text Key: 324795828
• Report Number: 9710055-2023-00736
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568852963
• Device Catalogue Number: ARD568852963
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention