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

Model Number	ARDPWT229114A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1b event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 24th october, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the light arms were scratched and some particles were missing.Photographic evidence indicated that paint was damaged with missing particles on arms and rust was present on arm.There was no injury reported, however, 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
Getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the light arms were scratched and some particles were missing.Photographic evidence indicated that paint was damaged with missing particles on arms and rust was present on suspension arm.There was no injury reported, however, 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 additional input from getinge employee it was possible to determine that the issue investigated herein is the same as already reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2024-00193).Following the detection of the issue in (b)(6) 2024, the quotation was not accepted by the customer and the issue has not been resolved.
Additional Manufacturer Narrative
It was confirmed that the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2024-0000583) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2024-00193) that has not been resolved by the customer since it was initially detected.The issue has been evaluated under manufacturer¿s reference number: (b)(4) (report number: 9710055-2024-00193).The correction of b5 describe event or problem, d1 brand name, h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the light arms were scratched and some particles were missing.Photographic evidence indicated that paint was damaged with missing particles on arms and rust was present on arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the light arms were scratched and some particles were missing.Photographic evidence indicated that paint was damaged with missing particles on arms and rust was present on suspension arm.There was no injury reported, however, 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 additional input from getinge employee it was possible to determine that the issue investigated herein is the same as already reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2024-00193).Following the detection of the issue in (b)(6) 2024, the quotation was not accepted by the customer and the issue has not been resolved.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled ii.Previous h4 device manufacture date: 09/25/2020.Corrected h4 device manufacture date: 09/28/2020.

• 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: 20576437
• Report Number: 9710055-2024-0000583
• Device Sequence Number: 15454478
• Product Code: FTD
• UDI-Device Identifier: 03700712406790
• UDI-Public: (01)03700712406790
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/31/2024

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: ARDPWT229114A
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown