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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Model Number IPN048387
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 09/30/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2022 that when the single-use blade was snapped on the laryngoscope handle, the guide light of the fiber optic (green tip) detached from the blade.There was no consequence for the patient.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
Event Description
It was reported on (b)(6) 2022 that when the single-use blade was snapped on the laryngoscope handle, the guide light of the fiber optic (green tip) detached from the blade.There was no consequence for the patient.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 4
Type of Device
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
angela meister
3015 carrington mill blvd
morrisville 27560
MDR Report Key15764616
MDR Text Key307561069
Report Number8030121-2022-00029
Device Sequence Number1
Product Code CCW
UDI-Device Identifier14026704663139
UDI-Public14026704663139
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN048387
Device Catalogue Number004551004
Device Lot Number220603341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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