MAUDE Adverse Event Report: MAQUET SAS POWERLED TM; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARD568411710A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2023 getinge became aware of an issue with one of our surgical lights configuration ¿ powerled.As it was stated, corrosion has built up on the spring arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
It was confirmed that the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00774) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00773).Therefore, the issue is evaluated under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00773).The correction of b5 describe event and problem, d1 brand name, d4 catalog #, 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 b5 describe event and problem: in 22th september, 2023 getinge became aware of an issue with one of our surgical lights configuration ¿ powerled 700 and powerled 300.As it was stated, corrosion has built up on the spring arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 22nd september, 2023 getinge became aware of an issue with one of surgical lights - powerled.As it was stated, corrosion has built up on the spring arm, forks, brake screws and collars.Then, photographic evidence confirmed that issue and also indicated that paint was damaged with missing particles on headlight and fork.It has come to customer attention that the cleaning agent used in their facility was the cause of the massive corrosion.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 or serious injury.Previous d1 brand name: powerled 700/300.Corrected d1 brand name: powerled tm.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.
Event or Problem Description
On 22nd september, 2023 getinge became aware of an issue with one of surgical lights - powerled.As it was stated, corrosion has built up on the spring arm, forks, brake screws and collars.Then, photographic evidence confirmed that issue and also indicated that paint was damaged with missing particles on headlight and fork.It has come to customer attention that the cleaning agent used in their facility was the cause of the massive corrosion.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 or serious injury.

• Brand Name: POWERLED TM
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 17955425
• Report Number: 9710055-2023-00774
• Device Sequence Number: 5263792
• Product Code: FSY
• UDI-Device Identifier: 03700712403003
• UDI-Public: (01)03700712403003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/18/2023

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: ARD568411710A
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 08/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown