MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. LAMP MODULE REPLACEMENT MLX; N/A

Catalog Number	001320LX
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the casing/plastic top and bottom part of the mlx lamp module replacement (001320lx) melted when installed in the light source.The device shut off after a few minutes.The problem was discovered before a procedure.No patient injury or death occurred.No surgical delay was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4 (udi #), d9, g3, g6, h2, h3, h10.Corrected field: d4 (serial number).The lamp module replacement mlx (001320lx) was returned for evaluation, along with the 00mlx xenon lightsource that the lamp module replacement was used with.Failure analysis - the lamp module replacement was received in used condition.Visual and functional checks were performed on the lamp.Visual inspection identified that the top and bottom of the lamp had melted.Functional inspection identified that the 00mlx lightsource did not turn on.Root cause - the reported complaint was confirmed.It was determined that the issue of the lamp module melting was most likely due to overheating caused by the fan malfunctioning in the 00mlx unit.The issue of the fan for this 00mlx unit malfunctioning was most likely due to a power supply failure caused by routine use and wear.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: LAMP MODULE REPLACEMENT MLX
• Common Device Name: 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: 18846551
• Report Number: 3006697299-2024-00023
• Device Sequence Number: 12702088
• Product Code: FCW
• UDI-Device Identifier: 10381780167969
• UDI-Public: 10381780167969
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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
• Operator of Device: Other
• Device Catalogue Number: 001320LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown