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

Model Number	ARDPWT629111A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site postal code: (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 - maquet powerled ii.It was stated the plastic cover has fallen off the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The correction of b5 describe event and problem and d4 unique identifier (udi) 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 - maquet powerled ii.It was stated the plastic cover has fallen off the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights - maquet powerled ii.It was stated the plastic joint cover has fallen off the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Previous d4 unique identifier (udi) #: (b)(4).Corrected d4 unique identifier (udi) #: (b)(4).Getinge became aware of an issue with one of surgical lights - maquet powerled ii.It was stated the plastic joint cover has fallen off the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.The device has been repaired by installing new joint cover (ard368937900) and returned to use.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.Root cause analysis was performed by subject matter expert at manufacturer¿s site.According to the photographic evidence a cover is missing at the bottom of the spring arm.It is probable that fixing screw was forgotten during installation, we have no further information.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 - maquet powerled ii.It was stated the plastic joint cover has fallen off the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

• 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: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 20770167
• Report Number: 9710055-2024-0000604
• Device Sequence Number: 4388406
• Product Code: FTD
• UDI-Device Identifier: 03700712425258
• UDI-Public: (01)03700712425258(11)231012
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/25/2024

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: ARDPWT629111A
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown