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

Model Number ARD568423210C

Device Problems Fracture (1260); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Initial reporter: getinge service technician.E1h event site postal code: (b)(6).E1i event site telephone: (b)(6).

Event Description

On 8th december 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700/700.As it was stated, upon the preventive maintenance activities being performed on the device, the following issues were found: two out of the six fixation screws holding the device main tube were broken and paint was chipping from fork.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury, and any paint particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: POWERLED
• 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: 18361735
• MDR Text Key: 330958106
• Report Number: 9710055-2023-00969
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/20/2023

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: ARD568423210C
• Device Catalogue Number: ARD568423210C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1