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

Model Number ARD568370939

Device Problems Leak/Splash (1354); Pitted (1460)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 3rd of september 2020 getinge became aware of an issue with one of our surgical lights - powerled.As it was stated, the sedimentation leakage on the spring arm was noticed.There was no injury reported however we decided to report the issue in abundance of caution and based on the potential as any liquid droplets falling off into sterile field or during procedure may lead to contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with a surgical light powerled device.The received customer allegation was pointing to non-functioning light due to loose sediment coming off from the space between spring arm and the fork.After device evaluation, the alleged sediment appeared to be caused by excessive cleaning solution being applied during cleaning.The cleaning agent was allowed to drip down and get in behind the retaining ring which consequently resulted in rust occurrence.There was no injury reported however we decided to report the issue in based on the potential as any article falling into the sterile field might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification as appearance of rust could be considered as technical deficiency.The device contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.The issue is indicated by our product experts to likely be caused by the concentration of chemical products and the stagnation of cleaning agent residues on the disinfected surfaces as the main factors leading to the deterioration of surfaces.This we believe is an effect of an user error, namely the customer not following cleaning protocol.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions given in the user manual (e.G.Ifu 01581/01601), avoiding spraying, high concentrations, prolonged exposure to detergents / disinfectants solutions, and to wipe with a dry cloth and to make sure 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 (e.G.01582/01602) mentions in the preventive maintenance to lubricate some parts of device.To prevent any incident the user manual (e.G.Ifu 01581/01601) mentions to perform daily inspections in order to detect paint defects, impact marks or other damages.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• 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
• MDR Report Key: 10507477
• MDR Text Key: 206142016
• Report Number: 9710055-2020-00360
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568370939
• Device Catalogue Number: ARD568370939
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1