MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number ARD568604999

Device Problems Detachment of Device or Device Component (2907); Misassembly During Maintenance/Repair (4054)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 14th september, 2020 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, screws responsible for fastening headlight's cover were loose.There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights ¿ lucea 50.The initial allegation was pointing to the cover of the device being broken.According to information provided by the getinge service technician the cover of the lucea device was not broken but disassembled by the customer from the device.The reason of the disassembly is suspected to be a loosened screw.The device at hand is being maintained by the customer himself, however no documented activity could be shown for this case.There was no injury reported however we decided to report the issue in abundance of caution as improperly installed cover may lead to parts falling and then might cause contamination.When reviewing similar reportable events registered for lucea 50 surgical light we established that the issue at hand is the first case of this nature.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification.The device at hand contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.Upon the performed investigation, we conclude the most likely root cause of the problem occurrence to be related to user error (loosening of the screws due to handling of the device via the cover and not via the designated handle) and most likely lack of correct maintenance of the device.We believe that remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature 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 50
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10660814
• MDR Text Key: 211503972
• Report Number: 9710055-2020-00408
• 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
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568604999
• Device Catalogue Number: ARD568604999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1