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

Model Number	ARD568371939
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the stop was broken.The fact that the stop is no longer functional is related to a unusual abrasion of the head screws, and therefore, can generate metal particles falling.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The initial reporter was an engineering.Initial reporter: (b)(6), event site name: (b)(6) hospital.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the stop was broken.The fact that the stop is no longer functional is related to a unusual abrasion of the head screws, and therefore, can generate metal particles falling.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.According to the subject matter expert at the manufacturer¿s, the problem with the stop¿s rotation reported on some pwd700 and hled 700 light heads is due to a lack of contact area between the stops.These stops realized with screw heads seem to be too short and become ineffective over time.The result is that the light can rotate freely, unplugging the cables and eventually creating some metal fillings.In september 2011, maquet sas has changed these screws in the production line but has not noticed any adverse outcome.Before this date, the screws were a bit longer, hence the stops stronger and should not be concerned by this problem.This issue was investigated through the capa 464134.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: POWERLED TM
• Common Device Name: 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: 21046813
• Report Number: 9710055-2024-0000648
• Device Sequence Number: 19652634
• Product Code: FSY
• UDI-Device Identifier: 03700712402761
• UDI-Public: (01)03700712402761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARD568371939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown