MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT AND CARRYING CASE; PFM05

Model Number	90620US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Three surgeons of the reporting facility expressed their dislike of the duo headlight 2 bay system ¿ us (90620us) and reportedly experienced pain and headaches.The following statements were reported: ¿the headlight severely hurts his head all over.¿ ¿not enough hinges for the flexibility of the light.Painful to wear.Two surgeons wearing the headlight at the same time smack into each other over the surgical field.¿ ".The headlight stick out too far into the surgical field.Pain and pressure which leads to tension headaches at the end of the case.¿ ¿the new headlight doesn¿t fit his head properly.¿ four (4) different serial numbers (sn) of the duo headlight were provided; however, it is unknown which specific device sn was used by each surgeon.
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
N/a.
Additional Manufacturer Narrative
Updated field: b5, d9, g3, g6, h2, h3, h6, h10, h11.Updated b5/additional information received: the customer reported that they "use the headlight for all specialties.There was no specific event.As seen in the comments the physicians interviewed felt pressure on their heads or it hurt".The customer subsequently provided five different serial numbers with corrected product id (90600).The customer was again unable to state which serial number was linked to the reported surgeons' dissatisfaction.Corrected d1, d4 (product id).The duo headlight and carrying case (90600) was not returned for evaluation; therefore, failure analysis could not be completed due to the lack of information received to perform a complete investigation.Based on the reported complaint, the probable root cause for the customer disliking these 90600 duo headlights is most likely due to customer preference.The reported complaint could not be confirmed.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• 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 ; 6099362319
• MDR Report Key: 16060126
• Report Number: 3006697299-2022-00180
• Device Sequence Number: 6733112
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 90620US
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/04/2023
• 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