MAUDE Adverse Event Report: TELEFLEX MEDICAL STORZ ILLUM, 3.5MM X 8' PILLING INSTR; SOURCE, CARRIER, FIBEROPTIC LI

Catalog Number	S358PRA
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during direct laryngoscopy, while using the philling light cord which was plugged into the arthrex light source, staff in the or smelled a burning smell.Subsequently, we removed the light cord and found that the tip of the light cord that enters into the light source had been burnt.The tip of the cord with the fibers were burnt as well.Patient seemed unaffected and equipment was turned off, removed, and tagged for further investigation.Surgeon, proceeded to do a vocal cord lesion excision, by microscope and did not see any harm to airway.".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during direct laryngoscopy, while using the philling light cord which was plugged into the arthrex light source, staff in the operating room smelled a burning smell.Subsequently, we removed the light cord and found that the tip of the light cord that enters into the light source had been burnt.The tip of the cord with the fibers were burnt as well.Patient seemed unaffected and equipment was turned off, removed, and tagged for further investigation.Surgeon, proceeded to do a vocal cord lesion excision, by microscope and did not see any harm to airway.".

• Brand Name: STORZ ILLUM, 3.5MM X 8' PILLING INSTR
• Common Device Name: SOURCE, CARRIER, FIBEROPTIC LI
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19374934
• Report Number: 3011137372-2024-00082
• Device Sequence Number: 20737933
• Product Code: EQH
• UDI-Device Identifier: 14026704658685
• UDI-Public: 14026704658685
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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
• Device Catalogue Number: S358PRA
• Device Lot Number: 1839-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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