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

Model Number ARDLCA219001C

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

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 12th march, 2022 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the cover was damaged, leading to missing plastic particles and the bolt was missing from handle holder.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or lead to serious injury.

Event Description

On 12th march, 2022 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the cover was damaged leading to missing plastic particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or lead to serious injury.

Manufacturer Narrative

Getinge became aware of an issue with lucea 100 surgical light.As it was stated, the cover was damaged, leading to missing plastic particles.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 or lead to serious injury.It was established that when the event occurred, the surgical light did not meet its specification due to particles missing from headlight covers, which contributed to the event.It is unknown if upon the event occurrence the device was or was not 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 particles missing from the headlight covers is low.As stated by subject matter expert at manufacturer, cracks located on the light head lower covers, at the edge of the on/off button, as recommended by the user manual.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.For cleaning, the user manual (nu_lucea_50_100_01741en_10 ¿ chapter 7) informs the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and to use inappropriate disinfectants.To prevent any incident the user manual (nu_lucea_50_100_01741en_10, page 26) mentions: ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would 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.The correction of d4 catalog #, d4 serial #, h6 component codes and b5 describe event or problem fields deems required.This is based on the internal evaluation.Previous d4 catalog # ardlca219001c.Corrected d4 catalog # ard568603999.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6), (b)(6).Previous h6 component codes: mechanical|cover||772.Mechanical|fastener|bolt|741 corrected h6 component codes: mechanical|cover||772.Previous b5 describe event or problem: on 12th march, 2022 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the cover was damaged, leading to missing plastic particles and the bolt was missing from handle holder.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or lead to serious injury.Corrected b5 describe event or problem: on 12th march, 2022 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the cover was damaged leading to missing plastic particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or lead to serious injury.

• Brand Name: LUCEA 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: 13927873
• MDR Text Key: 288115261
• Report Number: 9710055-2022-00098
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: HO
• 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
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA219001C
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1