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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH GREEN LITE BLADE MAC 4; LARYNGOSCOPE, RIGID
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TRUPHATEK INTERNATIONAL LTD. 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 Patient Involvement (2645)
Event Date 04/01/2017
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 still in progress.
 
Event Description
Customer complaint alleges the device was "found broken inside the packaging." usage of the device at the time of discovery is unknown.There was no report of patient involvement.It is unclear if it was in the clinical setting.
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.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 base of the blade was broken.The complaint is confirmed.It appears as though it sustained unexplained physical damage.It was confirmed that the device left the manufacturing facility fully functional.A capa was opened to address this issue.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
 
Event Description
Customer complaint alleges the device was "found broken inside the packaging." usage of the device at the time of discovery is unknown.There was no report of patient involvement.It is unclear if it was in the clinical setting.
 
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Brand Name
RUSCH GREEN LITE BLADE MAC 4
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 Key6705927
MDR Text Key79780584
Report Number8030121-2017-00115
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 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/28/2021
Device Catalogue Number4344
Device Lot Number1612342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received08/23/2017
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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