MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. XENON LIGHT SOURCE 300 WATT W/; 300W LS

Catalog Number	009300XSP
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
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 bracket in the light source (b)(6) that holds the lens has melted.This issue was discovered before a procedure.No patient injury occurred and no surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), d9, g3, g6, h2, h3, h6, h11.The suspected xenon lightsource (9300xsp) was not returned to the manufacturer; therefore, a definite root cause cannot be identified.Lot number information was not provided; therefore, manufacturing records could not be reviewed.Based on the reported complaint, the probable root cause for the bracket inside this 9300xsp lightsource being melted is overheating due to rough handling/environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: XENON LIGHT SOURCE 300 WATT W/
• Common Device Name: 300W LS
• 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 08540 ; 6099362319
• MDR Report Key: 19244091
• Report Number: 3006697299-2024-00053
• Device Sequence Number: 15327314
• Product Code: FCW
• UDI-Device Identifier: 10381780168089
• UDI-Public: 10381780168089
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 009300XSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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