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

Model Number ARD568603999

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

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

Event Type  malfunction  

Event Description

On 31st october, 2023 getinge became aware of an issue with one of surgical lights ¿ lucea 100.The designated complaint unit employee confirmed based on photographic evidence, the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any part or particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Initial reporter: (b)(6).Contact person phone number: (b)(6).Contact person e-mail address: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

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

Manufacturer Narrative

The problem was reported by medical technology.Getinge became aware of an issue with one of surgical lights ¿ lucea 100.The designated complaint unit employee confirmed based on photographic evidence, the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any part or particles falling off into sterile field or during procedure may cause contamination.The customer ordered the spare part ard368614998 in order to repair the device.Based on the information collected, it was established that when the event occurred, surgical light did not meet its specification due to cracked cover with missing particles which could be considered as technical deficiency, and in this way the device contributed to event.Provided information indicates that upon the event occurrence, the device was not being used for patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incident of cracked headlight cover with missing particles occurs at moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by the subject matter expert at manufacturing site, cracks located on the light head lower covers, at the edge of the on/off button, were detected during daily visual inspection, as recommended by the user manual (lucea 50-100 ifu 01741 rev.11, page 27).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 ifu (lucea 50-100 ifu 01741 rev.11, pages 46-48) 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 lucea 50-100 user manual (lucea 50-100 ifu 01741 rev.11) on page 27 mentions: ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections.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 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: 18280916
• MDR Text Key: 329895895
• Report Number: 9710055-2023-00941
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568603999
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1