MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568601997

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

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).Device not returned to manufacturer.

Event Description

On 28th march 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.

Event Description

On 21th march 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 28th march 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.Corrected b5 describe event and problem: on 21th march 2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, the headlight cover was broken resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.The affected device was repaired by replacing broken covers (ard368605998 - handle interface with fork - lucea 40, ard368606555 - transparent plastic cover - lucea 40).It was established that when the event occurred, the surgical light did not meet its specification due to cracks and missing particles from covers, which contributed to the event.Provided information does not indicate 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.We can assume that the failure ratio of cracks and missing particles on lucea 10/40 devices is moderate.A root cause analysis was performed by subject matter experts at manufacturing site.Based on some internal test done by maquet sas (ref: (b)(4) for instance), only abnormal use (violent collisions, excessive pressure¿) or the use of incompatible cleaning products or protocol, can damage this device as reported in this complaint.The user manual explains how to check the light heads during daily inspection (ifu_lucea_10_40_01701en12, pages 22-23).To avoid any similar incident, the lucea product must be used according with the user manual information (ifu_lucea_10_40_01701en12, pages 22-25).According to information provided by a getinge technician, the covers broke as a result of the user not using the handle on the lamp and gripping the lamp by the lens, confirming the root cause assessment.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 40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• 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: 16680955
• MDR Text Key: 312678520
• Report Number: 9710055-2023-00282
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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: ARD568601997
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1