MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. MLX 300W XENON LIGHTSOURCE; N/A

Catalog Number 00MLX

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

The mlx 300w xenon lightsource (00mlx) was brought in for not working.It was reported that the unit was producing a burning smell.When it was taken apart, lots of dust was found accumulated by the light bulb.Bulb was cleaned and tested again, and smoke started pouring out of the light source.The xenon lightsource was reopened and a loose tension clamp at the front was noted (attached to the top of light source door along with extra screws).Reporter is unsure of any other problems except the burning smell and smoke production.There was no patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Corrected b5: there was no patient involvement.The mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis - the mlx 300w xenon lightsource was received in used condition.The depot technician was able to duplicate the reported problem.Evaluation identified that the unit had physical damage.The bezel, ac entry module, right side panel, left side panel, turret, lamp, fans, and power supply unit all required replacement.Root cause analysis - the complaint reported by the customer was confirmed.The issue of this xenon lightsource emitting a burning smell and producing smoke was most likely due to rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

N/a.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17247228
• MDR Text Key: 318454602
• Report Number: 3006697299-2023-00069
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1