MAUDE Adverse Event Report: MAQUET SAS LUCEA 10; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568602971

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6), 2019 getinge became aware of an issue with one of surgical lights- lucea 10.As it was stated, the suspension arm almost detached from the main tube.There was no injury reported however we decided to report the issue in abundance of caution as unexpected detachment may lead to serious injury.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer's reference number: 264396.

Manufacturer Narrative

Getinge became aware of an issue with one of the lucea 10 light devices.It was reported to us initially that the suspension arm was showing early signs of breakage, which could consequently lead to detachment from the main tube.There was no injury reported, however we decided to report the issue based on the received indication and in abundance of caution - as a situation in which a suspension arm would actually detach may lead to serious injury.It was established that when the event occurred, the light did not meet its specification as it has been found that breakage of the weld occurred ¿ and this confirms that there was technical deficiency of the device (out of specification) and it contributed to event.In the time when the event occurred the device was not used for patient treatment.The device involved in this event has been identified as a lucea 10 model with the serial number (b)(4) and catalog number ard568602971.The manufacturing date of the device is (b)(6)2019.Device history record was reviewed and no anomalies were found.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death.Performed evaluation of returned parts revealed that although the cylinder pin, preventing the tube from falling out, was in its dedicated place however it has been broken in two places, what resulted in its function to be lost.This, in the worst case scenario, could cause the tube being completely uncoupled from the main axis and prevented from falling only by the harness cable.The root cause analysis was performed by the subject matter expert and supported with review of faulty parts received from the market.The conclusion is pointing to misuse being the main cause of pin breakage.When the arm of the device (oriented 90o to the main arm) is moved without loosening the clamping knob to release the pivot as described in the user manual nu_lucea_1001701 page 29 (positioning the light), a strong shearing effect is applied on the cylinder pin.With repetitive motions like this over time, it is probable that the pin can break.We believe that this type of our devices are performing correctly in the market.We also believe that if the manufacturer recommendation as described in the instructions for use and pertaining to avoidance of collisions and checks before use would have been followed the incident could have been avoided.

• Brand Name: LUCEA 10
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9289161
• MDR Text Key: 176251354
• Report Number: 9710055-2019-00319
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568602971
• Device Catalogue Number: ARD568602971
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1