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

Model Number	ARDPWT259052A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 12th september, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the rubber gasket fell off.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 700.It was stated the rubber gasket fell off.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.The information provided does not indicate whether the device was being used for patient treatment or diagnosis at the time of the incident.Root cause analysis was performed by the subject matter expert.It was detected that a peripheral seal is missing on a powerled ii 700 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.The correction of d4 catalog # and unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d4 version or model # ard569201917.Corrected d4 version or model # ardpwt259052a.Previous d4 catalog # ard569201917.Corrected d4 catalog # blank.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).The correction of d1 brand name deems required.This is based on the internal evaluation.Previous d1 brand name powerled ii.Corrected d1 brand name maquet powerled ii.

• 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: 20321170
• Report Number: 9710055-2024-0000535
• Device Sequence Number: 20834535
• Product Code: FTD
• UDI-Device Identifier: 03700712416379
• UDI-Public: (01)03700712416379
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/27/2024

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: ARDPWT259052A
• Device Catalogue Number: ARD569201917
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown