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

Model Number	ARDPWT259054A
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	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter was getinge service technician.Event site name: premier bone and joint.(b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 11th july, 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the headlight cover fasteners were broken in several locations around the cover.Parts of broken clip had fallen into the surrounding gasket and into the lighthead.It was confirmed by photographic evidence the headlight cover was cracked with missing particles in several locations.We decided to report the issue in abundance of caution as any 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
The unique identifier (udi) # information is not available as this medical device/model was marketed and/or discontinued in us before the udi requirement became mandatory.The correction of d1 brand name, d4 serial #, d4 catalog #, h4 manufacture date, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled ii.Previous d4 version of model # ard569201917.Corrected d4 version of model # ardpwt259054a.Previous d4 catalog # ard569201917.Corrected d4 catalog # none.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the headlight cover fasteners were broken in several locations around the cover.Parts of broken clip had fallen into the surrounding gasket and into the lighthead.It was confirmed by photographic evidence the headlight cover was cracked with missing particles in several locations.We decided to report the issue in abundance of caution as any 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 the event.There is no information if the claimed device was or was not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: the photographic evidences show cracks on the powerled ii plastic upper cover, these cracks are located around the fixing point of the cover.The cause is probably collisions with other equipment.The device has been repaired by replacement of pwdii-7-upper cover + handle (ard369221998) and returned to use.To prevent any incident the powerled ii instructions for use mentions to check that the device has not suffered any impact damage and to check for any chipped or cracked parts during the daily inspections before use.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 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: 19871948
• Report Number: 9710055-2024-00451
• Device Sequence Number: 7103753
• Product Code: FTD
• UDI-Device Identifier: 03700712408749
• UDI-Public: (01)03700712408749
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: ARDPWT259054A
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown