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

Model Number	ARDPWT259215A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the paint was chipped on the fork.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Initial reporter was infection prevention member employed by the account.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.Event site name: (b)(6).Event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
The correction of b5 describe event and problem 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 paint was chipped on the fork.We decided to report the issue in abundance of caution as any paint 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 and confirmed by photographic evidence that the paint was chipping on the fork.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the paint was chipped on the fork.The issue was also confirmed by photographic evidence.We decided to report the issue in abundance of caution as any paint 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.Based on an information gathered, the issue was discovered during an infection control rounding.Root cause analysis was performed by subject matter expert at the manufacturer.As they stated: it was confirmed that the cleaning has not been performed according to our ifu.Similar issues have been raised in the past.Over saturated rags are being used.The light is not dried of excess cleaner.A hydrogen peroxide based cleaner is being used.All of this has been brought up that it is harmful to the lights and the customer had been provided our suggested cleaning ifu.Hydrogen peroxide is an aggressive chemical agent for paint and this is the root cause of this paint chipping.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
Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence that the paint was chipping on the fork.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.

• 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: 20503504
• Report Number: 9710055-2024-0000576
• Device Sequence Number: 18240146
• Product Code: FTD
• UDI-Device Identifier: 03700712413897
• UDI-Public: (01)03700712413897
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/22/2024

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: ARDPWT259215A
• Device Catalogue Number: ARDPWT259215A
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown