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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 2; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 2; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004670002
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Medwatch# mw5094921.
 
Event Description
Medwatch complaint received: rush trulite secure single use laryngoscope handle blade combination by teleflex was being used for intubation of patient prior to surgery.Once activated by the anesthesia provider, the end of the blade where the light source is located began to smoke.The anesthesia provider then deactivated the laryngoscope and it was not used on the patient.Additional information from the customer reports there was no patient or provider harm.No medical intervention was required.The patient had been discharged from the hospital at the time of this report.
 
Manufacturer Narrative
(b)(4).Medwatch# mw5094921.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Medwatch complaint received: rush trulite secure single use laryngoscope handle blade combination by teleflex was being used for intubation of patient prior to surgery.Once activated by the anesthesia provider, the end of the blade where the light source is located began to smoke.The anesthesia provider then deactivated the laryngoscope and it was not used on the patient.Additional information from the customer reports there was no patient or provider harm.No medical intervention was required.The patient had been discharged from the hospital at the time of this report.
 
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Brand Name
RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 2
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10350294
MDR Text Key201196370
Report Number8030121-2020-00108
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date09/15/2022
Device Catalogue Number004670002
Device Lot Number1909621
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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