MAUDE Adverse Event Report: MAQUET SAS LUCEA 50/100; LAMP, SURGICAL

Model Number ARDLCA219002C

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

On 16th june, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was broken and label was torn.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The purpose of this submission is solely to provide a correction of d4 catalog #.This is based on the internal evalution.Previous d4 catalog # ardlca219002c.Corrected d4 catalog # ard568603999/ard568604999.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was broken and label was torn.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on information provided by getinge technician, the customer received quote for the repair and the status is currently pending his approval.Based on the information collected, it was established that when the event occurred, surgical lights did not meet their specification, since cracks in covers, resulting in missing plastic particles and torn label could be considered as technical deficiency, and in this way device contributed to event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at moderate ratio for the broken covers and very low ratio for the torn labels.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by subject matter expert at the manufacturing site and according to pictures provided, plastic top covers are deteriorated in corners and a broken parts are missing.The damages were probably caused by a collision.A new covers available as spare parts in the kit must be installed in order to replace damaged covers and to avoid any incident.To prevent any safety issue user manual for lucea 50/100 (ifu 01741 en 10, pages 26-27) mentions to check the light heads for chipped paint, impact marks and any other damage, during the daily check.The other issue concerning transparent sticker (label) which was torn and peeling off, as stated by the subject matter expert, it is not a label provided by maquet sas.Therefore, there could be no investigation performed to establish root cause.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: LUCEA 50/100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14772285
• MDR Text Key: 301382951
• Report Number: 9710055-2022-00225
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA219002C
• Device Catalogue Number: ARD568603999/ARD568604999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1