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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 4344
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is in progress.
 
Event Description
Customer complaint alleges the device was found broken inside the package.The alleged defect was reported as detected during use.There was no report of harm to the patient.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed on the reported lot number and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation.The manufacturing site (truphatek) reports that all blades are inspected prior to release, and can confirm that the blades leave the manufacturing site fully functional.It is not known when the breakage occurs.A capa was opened to address this issue with the broken blades.
 
Event Description
Customer complaint alleges the device was found broken inside the package.The alleged defect was reported as detected during use.There was no report of harm to the patient.Patient condition reported as "fine".
 
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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 Key6427237
MDR Text Key70640360
Report Number8030121-2017-00050
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/15/2017
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 No Information
Device Catalogue Number4344
Device Lot Number1611342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2017
Initial Date FDA Received03/23/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2016
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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