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

Catalog Number ARD568604999

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On 21st march, 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated the headlight cover was broken resulting in missing particle.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

Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated the headlight cover was broken resulting in missing particles, what was also confirmed by the photographic evidence.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.According to information provided by the getinge technician, the covers were broken due to user not using handle on the light and grabbing the light by the lens.Moreover, as its stated, this particular customer uses an ultraviolet light during cleaning procedures of the operation room and it causes plastic items to become brittle which could have contributed to the cover failure.The device has been repaired as broken parts s/a upper cover with fork v3 (ard368609996), s/a lower cover with dimer - l50 (ard368608998) and set transparent plastic cover ¿ l50 (ard368611998) were replaced.Based on the information collected, it was established that when the event occurred, surgical light did not meet its specification, as broken cover, resulting in missing plastic particles, could be considered as a technical deficiency, and in this way the device contributed to the event.There is no information if the device was or was not being used for a patient¿s treatment upon the event occurrence.The review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the cover¿s breakage, resulting in missing particles, is moderate.The analysis related to the issue of the cracked cover has been performed by the subject matter expert at the manufacturing site.As it stated, most probably root causes are: - prohibited products/or incorrect cleaning process.- an excessive tightening of the brake system.- an incorrect handling.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety ad essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ disinfection products test: maquet sas describe how to perform the material resistance test in the working instruction ref.Fl 007.To avoid degradation of the shell it is recommended to respect the contact time and to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.To prevent a similar incident, it is recommended to respect the cleaning instructions avoiding: - prolonged exposure to detergents and disinfectants solutions - high concentrations - prohibited products the user manual (01741 rev.10, pages 26-27) mentions also to perform daily inspection in order to check the presence of paint chip, impact marks or other damage.In (b)(6) 2015 a design change improved the braking system and the mechanical durability of the upper cover.The new spare part is available ref: ard368609996 in order to repair the damaged product.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s 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
• 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: 16689142
• MDR Text Key: 312774714
• Report Number: 9710055-2023-00294
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD568604999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1