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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. GREEN LITE BLADE MILL 0; LARYNGOSCOPE, RIGID
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TRUPHATEK INTERNATIONAL LTD. GREEN LITE BLADE MILL 0; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 4320
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 03/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the physician tested the device and "a piece of plastic breaks off".No patient involvement reported.
 
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 ma nufactured according to release specification.The manufacturing site reports "it is confirmed that a sample stuck in transit due to covid-19 lockdown announced in india since (b)(6) 2020 and is available for return.If in the event that the sample is delivered to the investigation site, the complaint will be reopened, and a sample investigation will be conducted.".
 
Event Description
It was reported the physician tested the device and "a piece of plastic breaks off".No patient involvement reported.
 
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Brand Name
GREEN LITE BLADE MILL 0
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TRUPHATEK INTERNATIONAL LTD.
netanya
MDR Report Key9930508
MDR Text Key189453617
Report Number8030121-2020-00061
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Catalogue Number4320
Device Lot Number1611402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Date Manufacturer Received05/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ULTRA-POWER LED HANDLE; ULTRA-POWER LED HANDLE
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