MAUDE Adverse Event Report: MAQUET SAS LUCEA 50/100; LAMP, SURGICAL

Model Number ARDLCA209012A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 26th march, 2024 getinge became aware of an issue with one of surgical lights - lucea 50.It was stated the cap on the spring arm was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

• Brand Name: LUCEA 50/100
• 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: katarzyna tkaczenko ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18996306
• MDR Text Key: 338906795
• Report Number: 9710055-2024-00233
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA209012A
• Device Catalogue Number: ARDLCA209012A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1