MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Model Number	ARDPWT209058A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 5th january, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, the white substance falling from the light head.It was determined that the cleaning fluid was collecting in the sterilizable handle assembly.Taking under consideration collected up to date information we decided to report this case based on potential as any drop could fall into sterile field and might cause contamination.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, the white substance was falling from the light head as an effect of the cleaning fluid accumulation in the sterilizable handle assembly.Taking under consideration information collected up to date we decided to report this case based on potential for serious injury if the issue was to reoccur as any drop could fall into sterile field and might cause contamination.Technician informed that the source of the substance was the cleaning method used by the customer, namely misused cleaning fluid being sprayed under pressure into the center light assembly, causing the cleaner to collect inside, drying and forming a white substance.To prevent similar cases from reoccurrence, the customer was instructed to use a cloth to wipe down the light instead of using the spray method.A light cleaning document, instructing on the proper cleaning was sent to the customer.It was established that when the event occurred, the surgical light did not meet its specification due to risk of falling cleaning substance and contributed to the event.None of information available to date suggest that at the time when the event occurred the device was being used for the patient treatment.A review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio is very low.According to subject matter expert, based on the information received from technician the root cause of this incident is wrong cleaning protocol, done probably with running water or spray directly applied onto the device.Manufacturer recommends to follow the user manual.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: POWERLED II
• Common Device Name: 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: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 16155677
• Report Number: 9710055-2023-00028
• Device Sequence Number: 7051709
• Product Code: FTD
• UDI-Device Identifier: 03700712407681
• UDI-Public: (01)03700712407681
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/13/2023

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: ARDPWT209058A
• Device Catalogue Number: ARDPWT209058A
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown