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

Model Number	ARDPWT609057A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter: (b)(6).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 ii.It was stated the seal on headlight has come off.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.
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 ii.It was stated the seal on headlight has come off.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.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.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.Root cause analysis was performed by subject matter experts at the manufacturer.As they stated: despite multiple follow-ups from the dcu, no information has been provided regarding the circumstances of this incident.It was detected a missing peripheral seal on a powerled ii 500 light head.The cause is unknown, no more detail was provided.To prevent any incident the powerled ii instruction for use ¿ifu 01811¿ mentions : ¿the product must not be modified in any way without the prior written consent of getinge¿ ¿check that the lighthead gaskets are in the proper position and in good condition¿ getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights- powerled ii.It was stated the seal on headlight has come off.The incident was initially assessed as reportable, as any parts falling off into sterile field or during procedure may cause contamination or injury.Recently, the incident has been reevaluated as new information become available, it was determined that the seal was loose on one side but did not come off.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: getinge became aware of an issue with one of surgical lights- powerled ii.It was stated the seal on headlight has come off.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.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights- powerled ii.It was stated the seal on headlight has come off.The incident was initially assessed as reportable, as any parts falling off into sterile field or during procedure may cause contamination or injury.Recently, the incident has been reevaluated as new information become available, it was determined that the seal was loose on one side but did not come off.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.Corrected h6 medical device ¿ problem code: material integrity problem|crack||1135.Previous h6 investigation conclusions: cause not established||4315.Corrected h6 investigation conclusions: cause traced to user||19.Getinge became aware of an issue with one of surgical lights- powerled ii.It was stated the seal on headlight has come off.The incident was initially assessed as reportable, as any parts falling off into sterile field or during procedure may cause contamination or injury.Recently, the incident has been reevaluated as new information become available, it was determined that the seal was loose on one side but did not come off.Therefore, the scenario described in the record is considered as non-reportable.The investigation was performed.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: MAQUET 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: sylviane boiron bourgeois ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 22457731
• Report Number: 9710055-2025-0000179
• Device Sequence Number: 8597578
• Product Code: FTD
• UDI-Device Identifier: 03700712423346
• UDI-Public: (01)03700712423346
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/09/2025

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: ARDPWT609057A
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/20/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown