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

Model Number ARD567910901

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights.As it was stated, the oil 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 oil droplets falling off into sterile field or during procedure may lead to contamination.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with spring arm of the powerled surgical light.As it was stated by the customer, an oil leakage from the spring arm was noticed.There was no serious injury reported however we decided to report the issue based on the potential as any droplets falling off into sterile field or during procedure might cause a contamination.It was established that when the event occurred, the surgical light did not meet the manufacturers specification as although no technical malfunction has been found, the situation which occurred was not in accordance to device specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that there is no apparent trend in the complaints.In the investigation course the product experts established that during the assembly of the spring arms the supplier applies a creamed grease, which is turning into the liquid above 135°c.Going further, the phenomenon described in the case at hand was most likely caused by a product coming from the outside (e.G.Cleaning agent applied in spray or with a sponge, but not in compliance with the recommendations given in our user manuals) and it mixing up with the grease.This is likely to occur due to the position of this metal tongue (located on the lower part of the spring arm on the bushing side) where an excess of liquid can be accumulated and consequently can mix with the grease to turn into a sort of greasy liquid.This greasy liquid is first accumulated in the inner side of the tongue and then goes out and fall.The second factor could be related to a combination of air conditioning and excess of oil at the bushing location.To prevent such situation from occurrence, the customer should follow the cleaning and disinfection procedure described in the user manual.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.

Event Description

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

Event Description

Manufacturer reference number 308656.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

• 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: 9933404
• MDR Text Key: 189922684
• Report Number: 9710055-2020-00081
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567910901
• Device Catalogue Number: ARD567910901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1