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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 IPN923885
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2023
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that "during intubation we observed that the blade was not stable (it was difficult to intubate when it should have been an straight forward intubation) with low visibility, the lighting was low.No clinical consequences for the patient.I managed to insert the et tube but it was a patient with no problems with ventilations and easy to intubate.Because of the low lighting source and blade instability, a procedure that should have been easy ended up being more complex that it should".No patient harm or injury.
 
Event Description
It was reported that "during intubation we observed that the blade was not stable (it was difficult to intubate when it should have been an straight forward intubation) with low visibility, the lighting was low.No clinical consequences for the patient.I managed to insert the et tube but it was a patient with no problems with ventilations and easy to intubate.Because of the low lighting source and blade instability, a procedure that should have been easy ended up being more complex that it should".No patient harm or injury.
 
Manufacturer Narrative
(b)(4), the complaint sample was returned to the manufacturing site.They reported, "the customer returned one blade of rusch greenlite mac 4 that belongs to old design for investigation.Visual inspection could not be performed as returned complaint device is for old design blade whereas customer reported the complaint for new designed blade.The device history record review for lot code: 230422341 per complaint notification summary was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The devices were tested for 100% functional testing prior to ship to customer.The root cause of the complaint is deemed to be "undetermined/unknown" because there is no actual complaint device returned for physical investigation.Corrective action is not required at this time as the root cause of this complaint is deemed unknown/undetermined as actual complaint device is not available or returned to determine the actual root cause.In the event if complaint device will be made available for physical investigation, then this complaint file will be re-opened to document the actual findings based on the physical investigation." teleflex will continue to monitor and trend for reports of this nature.
 
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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
mariah mackinnon
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18078652
MDR Text Key327612004
Report Number8030121-2023-00030
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/19/2023
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 Model NumberIPN923885
Device Catalogue Number004551004
Device Lot Number230422341
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/19/2023
Initial Date FDA Received11/06/2023
Supplement Dates Manufacturer Received12/11/2023
Supplement Dates FDA Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2023
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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