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

Model Number ARD567501995

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The initial reporter was a medical technician.Event site name: (b)(6) additional information will be provided following the conclusion of the investigation.

Event Description

On 23th april, 2024 getinge became aware of an issue with one of our surgical lights ¿ axcel.As it was stated, the handle was torn at screw holes.Based on the photographic evidence, the headlight handle interface ring was cracked resulting in possibility of missing particles and creating a risk of handle's detachment.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.

• Brand Name: AXCEL
• 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: 19190205
• MDR Text Key: 341130200
• Report Number: 9710055-2024-00302
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567501995
• Device Catalogue Number: ARD567501995
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1