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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 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been received for evaluation by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges "the handles were broken at the junction point in the package." there was no report of patient involvement.It is unclear if the alleged defect reported was found in the clinical setting.
 
Manufacturer Narrative
(b)(4).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 was broken.These products are inspected prior to release from the manufacturing facility; therefore, it can be confirmed that the device left the manufacturing site fully functional.It seems that for some reason it sustained unexplained physical damage.A capa was opened to address this issue.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be established.
 
Event Description
Customer complaint alleges "the handles were broken at the junction point in the package." there was no report of patient involvement.It is unclear if the alleged defect reported was found in the clinical setting.
 
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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 Key6710025
MDR Text Key79905619
Report Number8030121-2017-00117
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 company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/19/2017
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 Number004551004
Device Lot Number1704341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2017
Initial Date FDA Received07/13/2017
Supplement Dates Manufacturer Received06/19/2017
Supplement Dates FDA Received08/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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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