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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 Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
It was reported that "the blades don't hold onto the handle during use." additional information has been requested from the account.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).New information received from the customer indicates that this was not a reportable event, thus, the initial mdr submitted on 21-feb-2024 should be retracted.
 
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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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18745993
MDR Text Key335810379
Report Number8030121-2024-00006
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,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/29/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/21/2024
Supplement Dates Manufacturer Received01/29/2024
Supplement Dates FDA Received03/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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