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

Model Number LUCEA 50/100

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of surgical lights - lucea.The fell of the upper and lower covers occurred.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination.

Event Description

Manufacturer 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.

Manufacturer Narrative

The correction of b5 describe event or problem deems required.This is based on the internal evaluation.Previous describe event or problem: on 17th november, 2021 getinge became aware of an issue with one of surgical lights - lucea.The fell of the upper and lower covers occurred.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination.Corrected describe event or problem: on 16th november, 2021 getinge became aware of an issue with one of surgical lights - lucea.The fell of the upper and lower covers occurred.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination.Getinge became aware of an issue with one of surgical lights - lucea.The fell of the upper and lower covers occurred.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination.Based on provided report, a ssu technician performed disassembly and replacement of the upper and lower covers, as well as the transparent shell.The device passed functional tests.It was established that when the event occurred, the surgical light did not meet its specification due to fall off the headlights cover, which contributed to the event.Provided information do not indicate if upon the event occurrence the device was being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of headlight covers falling off occurrence is low.Unfortunately, maquet did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.However, as stated by subject matter expert at manufacturer, the most probable root cause is related to improper use or misuse of the equipment (e.G.Collision).Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 16th november, 2021 getinge became aware of an issue with one of surgical lights - lucea.The fell of the upper and lower covers occurred.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination.

• 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: 13076900
• MDR Text Key: 282713209
• Report Number: 9710055-2021-00383
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LUCEA 50/100
• Device Catalogue Number: ARD568604998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1