MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO CUFF PILOT SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	1D2030
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Upper Respiratory Tract Injury (4599)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "an lma bronchoscope got stuck and when attempting to release it, hit the vocal cord causing minimal trauma - mild irritation & erythema where the scope passed.Sore throat was determined likely, no bleeding or inability to eat to our knowledge.No emergency care was required.They were able to be discharged from the op procedure as expected.".
Additional Manufacturer Narrative
(b)(4).The representative sample was returned to the manufacturer for evaluation.The manufacturer reported: according to the device history record review, no abnormality was found.The sample return to manufacturing site was not the actual sample but representative sample from same lot.Based on the complaint description, the lma evo cuff pilot device was used, followed by the insertion of the fiberoptic bronchoscope.The complaint description only mentioned that the bronchoscope became stuck, and during it release, it hit the patient's vocal cords.No further details were provided.According to the ifu, the bronchoscope (in the et tube) should be release through the et tube once the et tube is correctly placed in the patient's trachea.The root cause of the complaint could not be determined because it was unclear how the process was carried out in relation to the ifu, and whether the equipment was adequately lubricated.
Event or Problem Description
It was reported that: "an lma bronchoscope got stuck and when attempting to release it, hit the vocal cord causing minimal trauma - mild irritation and erythema where the scope passed.Sore throat was determined likely, no bleeding or inability to eat to our knowledge.No emergency care was required.They were able to be discharged from the op procedure as expected.".

• Brand Name: LMA UNIQUE EVO CUFF PILOT SIZE 3
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21535601
• Report Number: 3009307931-2025-00003
• Device Sequence Number: 12526462
• Product Code: CAE
• UDI-Device Identifier: 15060112318877
• UDI-Public: (01)15060112318877(11)240816(17)270816(10)11F24H0140(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Catalogue Number: 1D2030
• Device Lot Number: 11F24H0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 107 KG