MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

Catalog Number	90620US
Medical Device Problem Codes	Overheating of Device (1437); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1/full name of the reporting facility: (b)(6) medical center.The duo headlight 2 bay system - us (90620us) was returned for evaluation:   failure analysis - the duo headlight was received in used condition.Evaluation identified that the headlight had loose debris inside the luminaire leading to the light tests failure.In addition, the snorkel edge and the power cord connector rubber cover were detached.  root cause analysis - the reported complaint was confirmed.The issue of this duo headlight overheating and flickering is most likely due to rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
A facility reported that after 20 minutes of use, the duo headlight 2 bay system - us (90620us) started to overheat and the beam began to flicker.There was no patient involvement; thus, no patient injury, death or surgical delay was reported.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Common Device Name: PFM05
• 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: 19443235
• Report Number: 3006697299-2024-00071
• Device Sequence Number: 8545633
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K 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
• Report Date (Section B): 06/01/2024

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: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 06/01/2024
• 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