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

Model Number	ARD568411110A
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was getinge technician.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the rust occurred on spring arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
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 rust occurred on spring arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.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.The photographic evidence shows rust formation and paint peeling on the device.It can be observed that the degradation of the paint and corrosion are mostly localized on the retention areas which shows that the stagnation of liquid or cleaning agent residues have caused paint damages and appearance of rust.Peeling paint and/or rust formation were probably caused by: a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol.The presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use; the relative humidity must be between 20% and 75%.To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages.The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.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: 20661297
• Report Number: 9710055-2024-0000592
• Device Sequence Number: 7305004
• Product Code: FSY
• UDI-Device Identifier: 03700712402990
• UDI-Public: (01)03700712402990
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Device Model Number: ARD568411110A
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown