MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; LIGHT, SURGICAL, CEILING MOUNTED

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Injury (2348)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On the (b)(4) maquest (b)(4) became aware of an incident with lucea 40 device.It was stated that the cover of the light fell of and hit the patient.There was no injury reported.No furhter information was provided so far.The issue is being investigaed.

Manufacturer Narrative

The issue is stll being investigated by manufacturing site.

Event Description

Manufacturer reference number # (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, (b)(4).Maquet sas became aware of an incident with surgical light lucea device.It was stated that the cover of the light fell off and made a contact with the patient during procedure.There was no injury reported.It was established that when the event occurred, the light-head did not meet its specification and it contributed to the event.At the time when the event occurred the device was being used for the patient treatment.During the investigation it was found that there is no apparent trend and that the reported scenario has never lead to serious injury or worse.The manufacturer has performed an investigation for that case.Unfortunately, we did not receive the information about cleaning products used to clean the device.According to the part evaluation, our product knowledge and based on the previous complaint and on internal tests (cre 12-085), only unexpected use or the use of incompatible cleaning products or wrong cleaning protocol appears likely to damage the device as reported in the complaint.To prevent any other similar case, maquet sas recommends in the lucea 40 user manual 01711en ed.03 how to clean the device.What is more, it is recommended by maquet to daily check the device for chipped paint, impact marks and any other damage.We believe that if the manufacturer recommendation in the ifu would have been followed the incident would have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: LUCEA 40
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 6804001
• MDR Text Key: 83259355
• Report Number: 9710055-2017-00052
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2018

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 07/17/2017; 07/17/2017
• Supplement Dates FDA Received: 01/29/2018; 03/20/2018; 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1