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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH GREEN RUSCHLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID
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TRUPHATEK INTERNATIONAL LTD. RUSCH GREEN RUSCHLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551003
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation for this complaint is in progress at the time of this report.
 
Event Description
The customer complaint alleges blades were broken prior to use.They open the package and pieces fallout from the fiber optic light bundle.The alleged defect was detected prior to use, during pretesting.There was no report of patient involvement.
 
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 according to release specification.The sample was returned for evaluation.A visual exam was performed and it was observed that the blade was broken.It is unknown where the damage occurred as all products are inspected at the manufacturing facility prior to shipment; therefore, a defect of this type would be detected prior to release.The complaint was confirmed; however, a root cause could not be established.A capa was opened to further address this issue.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
 
Event Description
The customer complaint alleges blades were broken prior to use.They open the package and pieces fallout from the fiber optic light bundle.The alleged defect was detected prior to use, during pretesting.There was no report of patient involvement.
 
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Brand Name
RUSCH GREEN RUSCHLITE DISP MTL MAC 3
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TRUPHATEK INTERNATIONAL LTD.
netanya
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 Key6060107
MDR Text Key58524403
Report Number8030121-2016-00013
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number004551003
Device Lot Number1604332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Yes
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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