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

Model Number 90620US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994)

Event Type  Injury  

Event 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.

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 Description

N/a.

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
• Type of Device: 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
• MDR Text Key: 306253696
• Report Number: 3006697299-2022-00180
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 90620US
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1