MAUDE Adverse Event Report: MAQUET SAS LUCEA; LAMP, SURGICAL

Model Number ARD568603999

Device Problems Crack (1135); Peeled/Delaminated (1454)

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 20th november 2020 getinge became aware of an issue with one of our light - lucea 100.As it was stated the fork of the device was damaged and welded part was not blocked resulting in unexpected rotation.Moreover paint damage has been discovered on the device.No information about any injury has been reported, however we decided to report this case in abundance of caution as any objects falling down into sterile field may led to serious injury.

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

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

Manufacturer Narrative

On 20th november 2020 getinge became aware of an issue with one of our surgical lights - lucea 100.The fork of the device was damaged and welded part was not blocked resulting in unexpected rotation leading to paint damage due to not intended movement.No information about any injury has been reported, however, we decided to report this case in abundance of caution as any paint particles falling down into sterile field may led to contamination.It was established that when the event occurred, the surgical light did not meet its specification as a crack of welding between a fork and an axle leading to paint chipping had occurred and thereby it contributed to the event.It is unknown if the device was being used for the patient treatment at the time of the event.The manufacturer¿s subject matter experts have investigated the issue and the probable root cause has been established.Since july 2015, from the serial number (b)(6), by the design change request, the connection between the fork and the axle is welded with a plug.To validate the design change a lucea 100, equipped with a welded fork, was tested by tensile and torsion test.The test report, performed according to the standard iec 60601-1 ed.3, mentions that, during tensile and torsion tests, no crack was detected when a 100 n effort was applied and no fracture was detected when 250 nm was applied.The serial number of light head involved is higher than (b)(6) and correspond to the welded design.The welded connection, between the fork and the axle, of the device involved, probably broke by repetitive and excessive effort > 250 n.The tearing of the welded joint led to paint chipping around the mechanical connection axle/fork.The fork involved must be replaced by ard368614998 including the lower cover.To prevent any incident, the lucea 50-100 instruction for use, mentions to check the lightheads, during daily inspections before use, for chipped paint and any damage, and to operate the device making several movements to detect any stability issue.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5 describe event or problem section deemed required.This is based on the technical evaluation of the issue.Previous b5: on 20th november 2020 getinge became aware of an issue with one of our light - lucea 100.As it was stated the fork of the device was damaged and welded part was not blocked resulting in unexpected rotation.Moreover paint damage has been discovered on the device.No information about any injury has been reported, however we decided to report this case in abundance of caution as any objects falling down into sterile field may led to serious injury.Corrected b5: on 20th november 2020 getinge became aware of an issue with one of our surgical lights - lucea 100.The fork of the device was damaged and welded part was not blocked resulting in unexpected rotation leading to paint damage due to not intended movement.No information about any injury has been reported, however, we decided to report this case in abundance of caution as any paint particles falling down into sterile field may led to contamination.

Event Description

On 20th november 2020 getinge became aware of an issue with one of our surgical lights -lucea 100.The fork of the device was damaged and welded part was not blocked resulting in unexpected rotation leading to paint damage due to not intended movement.No information about any injury has been reported, however, we decided to report this case in abundance of caution as any paint particles falling down into sterile field may led to contamination.

• Brand Name: LUCEA
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10910396
• MDR Text Key: 218693803
• Report Number: 9710055-2020-00485
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568603999
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1