MAUDE Adverse Event Report: MAQUET SAS POWERLED; 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
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the corrosion has built up on the spring arms.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 rust particles falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).Event site telephone: (b)(6).H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the corrosion has built up on the spring arms.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 rust particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the brake screws and collars were rusted.Photographic input 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.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the brake screws and collars were rusted.Photographic input 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.
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 arms, brake screws and collars.Photographic input 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.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, 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: on 22nd september, 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the brake screws and collars were rusted.Photographic input 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.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 arms, brake screws and collars.Photographic input 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 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.Getinge became aware of an issue with one of surgical lights - powerled.As it was stated, corrosion has built up on the spring arms, brake screws and collars.Photographic input 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.It was established that when the event occurred, the surgical light did not meet its specification due to rust occurrence and paint peeling, which contributed to the event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of paint peeling on powerled and hled surgical lights, there is one event which led to the serious injury.No such events for rust occurrence issue.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of rust occurrence is moderate, and for paint peeling is also moderate.As stated by subject matter expert at manufacturer¿s, the concentration of chemical products and the stagnation of cleaning agent residues on the disinfected surfaces are the main factors leading to the deterioration of surfaces.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions avoiding spraying, high concentrations, prolonged exposure to detergents/disinfectants solutions, and to wipe with a dry cloth and to make sure that no liquid residue is left on the device after cleaning.To reduce the appearance of rust or the degradation of the surface, the technical manual or maintenance manuals mentions in the preventive maintenance to lubricate some parts of device.To prevent any incident the user manuals, mention to perform daily inspections in order to detect paint defects, impact marks or other damages.Maquet sas recommends to perform corrective maintenance to rectify the default after its detection.Minor paint chips can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED
• 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: 17955428
• Report Number: 9710055-2023-00775
• Device Sequence Number: 20149533
• 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,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
• Device Catalogue 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: 10/27/2023; 05/10/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/17/2023; 05/10/2024
• 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