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

Model Number	AX2100BIF
Medical Device Problem Codes	Crack (1135); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
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
The following information was reported via medsun uf/importer report# (b)(4): "head lamp used by surgeon was noted to have cracked insulation/wire causing heat to build up (fire hazard).Noticed during plugging/unplugging for xray intra-op.The unit was switched out with new one.Test performed (b)(6) 2022; results: headlamp sent to biomed department for evaluation and correction.Have 2 new headlamps on order." no patient/user injury, death or surgical delay was reported.
Additional Manufacturer Narrative
The suspected ultralite pro headlight w/premium cable (ax2100bif) was not returned for evaluation after three good faith efforts (gfe).The lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.A definitive root cause could not be determined.The issue of cracked insulation may be the result of rough handling, environmental damage, or wear.
Event or Problem Description
N/a.

• 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: 15775314
• Report Number: 3006697299-2022-00153
• Device Sequence Number: 4923758
• Product Code: FCW
• UDI-Device Identifier: 10381780168850
• UDI-Public: 10381780168850
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2023

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 01/29/2023
• 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