MAUDE Adverse Event Report: TELEFLEX MEDICAL TRULITE SECURE SU BLADE-HANDLE MILL 0; LARYNGOSCOPE, RIGID

Catalog Number	004670000
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "blade size 0 is larger in diameter than expected, the end/tip of the blade is wider and sharp.The blade design does not accurately match the standard miller blade profile.An ova has been raised after a failed intubation case (two unsuccessful attempts), resulting in patient compromise." additional information received on (b)(6) 2026, indicated that "no harm or health consequences to the patient, patient's current condition is good.No medical intervention required.A very sharp edge of the laryngoscope is observed, and the end-users believe that the failed intubation is because of the sharp back edge of the laryngoscope and dimensional differences.Both failed intubation attempts were on the same patient.The reported design and dimensional differences were identified after intubation failure.".

• Brand Name: TRULITE SECURE SU BLADE-HANDLE MILL 0
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25311068
• Report Number: 8030121-2026-00001
• Device Sequence Number: 12136485
• Product Code: CCW
• UDI-Device Identifier: 14026704711540
• UDI-Public: (01)14026704711540(11)240806(17)270805(10)240806601(21)
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2026

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: 004670000
• Device Lot Number: 240806601
• 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: 05/10/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2024
• 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: NONE REPORTED.
• Patient Sex: Unknown