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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MILL 2; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MILL 2; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004550002
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Medwatch complaint received: during intubation it was noted by the anesthesia provider that a small plastic piece had broken off the laryngoscope blade and was visualized in the back of the throat.Multiple attempts to locate and retrieve it were made by the anesthesia provider, the anesthesiologist in charge, a pulmonary doctor, and a general surgeon.The broken piece was located and retrieved by the general surgeon.Additional information was requested, but not received at the time of this report.
 
Manufacturer Narrative
(b)(4).Medwatch uf/importer report# (b)(4).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: during intubation it was noted by the anesthesia provider that a small plastic piece had broken off the laryngoscope blade and was visualized in the back of the throat.Multiple attempts to locate and retrieve it were made by the anesthesia provider, the anesthesiologist in charge, a pulmonary doctor, and a general surgeon.The broken piece was located and retrieved by the general surgeon.Additional information was requested, but not received at the time of this report.
 
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Brand Name
RUSCH GREENLITE DISP MTL MILL 2
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9350019
MDR Text Key189448989
Report Number8030121-2019-00106
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 other,user facility
Type of Report Initial,Followup
Report Date 10/30/2019
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 Operator Health Professional
Device Expiration Date03/08/2024
Device Catalogue Number004550002
Device Lot Number1904421
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received12/16/2019
Supplement Dates FDA Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
Patient Outcome(s) Required Intervention;
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