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

Model Number ARD568370934

Device Problems Corroded (1131); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.At the time of initial information the customer allegation was not considered as safety related issue.On 9th june 2023, service technician arrived on site and found upon the device inspection defective fixation screws holding the device main tube and corrosion built up on the cover.There was no injury reported, however, we decided to report the issue in abundance of caution as defective screws holding the device configuration may lead to the device detachment from the ceiling and serious injury and any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3: device not returned to manufacturer.

Manufacturer Narrative

We would like to provide an update on the initially submitted information.Upon further clarifications, it was possible to determine that no deficiency of the fixation screws was found.The screws were replaced preventively following the manufacturer's recommended maintenance schedule.Therefore, the initially considered issue with defective fixation screws is not safety and risk related.We will continue to investigate the corrosion built up on the cover.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem, h6 medical device ¿ problem code and h6 component codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 7th april 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.At the time of initial information the customer allegation was not considered as safety related issue.On 9th june 2023, service technician arrived on site and found upon the device inspection defective fixation screws holding the device main tube and corrosion built up on the cover.There was no injury reported, however, we decided to report the issue in abundance of caution as defective screws holding the device configuration may lead to the device detachment from the ceiling and serious injury and any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 7th april 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.At the time of initial information the customer allegation was not considered as safety related issue.On 9th june 2023, service technician arrived on site and found upon the device inspection corrosion built up on the cover.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.Previous h6 medical device ¿ problem code: material integrity problem|break|fracture|1260.Mechanical problem|detachment of device or device component||2907.Material integrity problem|degraded|corroded|1131.Corrected h6 medical device ¿ problem code: material integrity problem|degraded|corroded|1131.Previous h6 component codes: mechanical|cover||772.Mechanical|coating material||4768.Mechanical|fastener|screw|568.Corrected h6 component codes: mechanical|coating material||4768.

Event Description

On 7th april 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.At the time of initial information the customer allegation was not considered as safety related issue.On 9th june 2023, service technician arrived on site and found upon the device inspection corrosion built up on the cover.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 Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

On 7th april 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.At the time of initial information, the customer allegation was not considered as a safety related issue.On 9th june 2023, service technician arrived on site and found upon the device inspection corrosion built up on the cover.There was no injury reported, however, we then 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 an information gathered, defective parts were replaced.It was established that when the event occurred, the surgical light did not meet its specification due to rust, which contributed to the event.Based on information gathered during the investigation, it was possible to establish that the device was not used for patient treatment upon event occurrence.The issue was discovered by getinge technician who performed the maintenance.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue rust on powerled and hled surgical lights, there is no event which led to the serious injury.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of rust occurrence is 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 (attachment 2 ¿ ifu_powerled_01581, pages 35-38) 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 (attachment 3 ¿ technicalmanual_powerled_01582en08, page 254).To prevent any incident the user manuals, mention to perform daily inspections in order to detect paint defects, impact marks or other damages (attachment 2 ¿ ifu_powerled_01581, pages 20-22).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
• Type of Device: 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: 17197597
• MDR Text Key: 317819982
• Report Number: 9710055-2023-00473
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2023

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 Operator: Other
• Device Model Number: ARD568370934
• Device Catalogue Number: ARD568370934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 03/06/2024
• Supplement Dates FDA Received: 07/05/2023; 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1