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

Model Number ARD568601997

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

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1.Event site postal code: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On (b)(6)2023 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated and confirmed with photographic evidence, the cover was cracked resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.

Manufacturer Narrative

The facility management was the initial reporter.Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated and confirmed with photographic evidence, the cover was cracked resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.The affected device was repaired by replacing broken cover (ard368605998 - handle interface with fork - 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 cover, which contributed to the event.Provided information indicate that upon the event occurrence the device 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: cre 12-085 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).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.

Event Description

Manufacturer's reference number (b)(4).

• 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: 17141495
• MDR Text Key: 317330033
• Report Number: 9710055-2023-00444
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/16/2023

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 Operator: Health Professional
• 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: 06/08/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1