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

Model Number ARDLCA219001A

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 3rd december, 2020 getinge received customer product complaint where an issue with one of surgical lights occurred - lucea.As it was stated, the crack of the cover occurred, leading to cover's detachment.There were no injuries reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.During further clarification of the issue with service unit, additional details have been obtained.Based on that, the description of the problem will be corrected.Previous b5 describe event or problem "on 3rd december, 2020 getinge received customer product complaint where an issue with one of surgical lights occurred - lucea.As it was stated, the crack of the cover occurred, leading to cover's detachment.There were no injuries reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.".Corrected b5 describe event or problem."on 3rd december, 2020 getinge received customer product complaint where an issue with one of surgical lights occurred - lucea.Initial allegation was the crack of the cover occurred.Photo evidence was showing lack of cover, so it was suspected that it has detached.Further clarification of the issue reveled that the cover has been removed by the customer.There were no injuries reported however based on initial allegation and photo evidence we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.".

Event Description

On 3rd december, 2020 getinge received customer product complaint where an issue with one of surgical lights occurred - lucea.Initial allegation was the crack of the cover occurred.Photo evidence was showing lack of cover, so it was suspected that it has detached.Further clarification of the issue reveled that the cover has been removed by the customer.There were no injuries reported however based on initial allegation and photo evidence we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Getinge received customer product complaint where an issue with one of surgical lights occurred - lucea.Initial allegation was the crack of the cover occurred.Photo evidence was showing lack of cover, so it was suspected that it has detached.Further clarification of the issue reveled that the cover has been removed by the customer.There were no injuries reported however based on initial allegation and photo evidence we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification as it was damaged and particles were missing, and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: mechanical stress, environmental conditions (such a high temperature and humidity variations during transport and storage), use of inappropriate cleaning/disinfections products, or inappropriate cleaning and disinfection protocols.We believe that overall the devices on the market are performing correctly.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA 100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10977290
• MDR Text Key: 220488549
• Report Number: 9710055-2020-00502
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA219001A
• Device Catalogue Number: ARDLCA219001A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1