MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE; IMIG

Model Number	AX2100BIF
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that there was broken glass or mirror at the lamp of the ultralite pro headlight w/premium cable (ax2100bif) and the unit emits multiple light focus areas.This was discovered by the facility¿s biomed following report of overheating.The biomed reportedly found no issue with the unit but during testing, the damage to the headlamp was discovered.It is unknown if there was patient involvement; however, no injury, death or surgical delay was reported.
Additional Manufacturer Narrative
The ultralite pro headlight w/premium cable (ax2100bif) was returned for evaluation.Device history record (dhr): dhr shows no abnormalities related to the reported issue.Failure analysis: the depot technician assessment of the ultralite pro headlight found that the lens inside the module was cracked.The module has been replaced to correct this issue.Root cause: evaluation of the ultralite pro headlight identified that the unit was in used condition with damage to the lens due to rough handling/environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE
• Common Device Name: IMIG
• 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: 14760365
• Report Number: 3006697299-2022-00089
• Device Sequence Number: 11086133
• Product Code: FCW
• UDI-Device Identifier: 10381780168850
• UDI-Public: 10381780168850
• Combination Product (Y/N): N
• PMA/510(K) Number: K864380
• 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
• Report Date (Section B): 06/21/2022

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: Health Professional
• Device Model Number: AX2100BIF
• Device Catalogue Number: AX2100BIF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/21/2022
• 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