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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH GREENLED HANDLE, MEDIUM; LARYNGOSCOPE, RIGID
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TRUPHATEK INTERNATIONAL LTD. RUSCH GREENLED HANDLE, MEDIUM; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 4215
Device Problem Optical Problem (3001)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the light flickered due to bad electrical contact during pretest.No patient involvement.
 
Manufacturer Narrative
(b)(4).The investigative site reports the sample was collected, but the package was misplaced during the pandemic lockdown period and therefore a physical investigation could not be completed.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available for investigation at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported that the light flickered due to bad electrical contact during pretest.No patient involvement.
 
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Brand Name
RUSCH GREENLED HANDLE, MEDIUM
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TRUPHATEK INTERNATIONAL LTD.
netanya
MDR Report Key9528316
MDR Text Key189446845
Report Number8030121-2019-00117
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 company representative,foreig
Type of Report Initial,Followup
Report Date 12/05/2019
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 Number4215
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/28/2019
Supplement Dates Manufacturer Received09/07/2020
Supplement Dates FDA Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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