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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN LITE BLADE MAC 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREEN LITE BLADE MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551004
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).It is unknown if the device is available for evaluation at the time of this report.Teleflex has requested this information.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges "problem to connect the handle and the blade.The blade was broken in the packaging." usage of the device at the time of the alleged defect is unknown.No report of patient involvement.
 
Manufacturer Narrative
Qn# (b)(4).Corrected data: manufacturer corrected to teleflex medical, (b)(4).Catalog # corrected to 004551004.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured as per release specification.The sample was returned for evaluation.A visual exam was performed and it was observed that the base of the light guide was broken.Based on the visual exam, the reported complaint was confirmed.A capa was opened to address this issue.
 
Event Description
Customer complaint alleges "problem to connect the handle and the blade.The blade was broken in the packaging." usage of the device at the time of the alleged defect is unknown.No report of patient involvement.
 
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Brand Name
RUSCH GREEN LITE BLADE 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
9194334854
MDR Report Key6993870
MDR Text Key91925942
Report Number8030121-2017-00132
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number004551004
Device Lot Number1707341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
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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