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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENSPEC STUBBY HANDLE; LARYNGOSCOPE HANDLE
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TELEFLEX MEDICAL RUSCH GREENSPEC STUBBY HANDLE; LARYNGOSCOPE HANDLE Back to Search Results
Catalog Number 004413300
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The complaint alleges that the handle gets very hot once the batteries are installed and the light is engaged.The alleged defect occurred prior to pt use during functionality testing.There was no report of pt harm or injury.
 
Manufacturer Narrative
The sample was returned for evaluation, however, the investigation was not complete at the time of this report.A follow-up report will be submitted upon completion of the investigation.
 
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Brand Name
RUSCH GREENSPEC STUBBY HANDLE
Type of Device
LARYNGOSCOPE HANDLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck dr.
research triangle park NC 27709
Manufacturer Contact
katharine tarpley,
po box 12600
research triangle park, NC 27709
9194334854
MDR Report Key3955707
MDR Text Key20452971
Report Number1044475-2014-00173
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 User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/30/2014
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 Other
Device Catalogue Number004413300
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/30/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/30/2014
Initial Date FDA Received06/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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