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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT; MRI LARYNGOSCOPE KIT
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TELEFLEX RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT; MRI LARYNGOSCOPE KIT Back to Search Results
Catalog Number 005852300
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 09/26/2014
Event Type  malfunction  
Event Description
The complaint alleges that the handle stopped working.There were no reports of patients harm or injury.
 
Manufacturer Narrative
A device history record (dhr) review could not be performed as the lot number was unknown.The sample was not returned for evaluation, therefore, the complaint could not be confirmed.If the sample is received, a follow-up report will be submitted with investigation results.
 
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Brand Name
RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT
Type of Device
MRI LARYNGOSCOPE KIT
Manufacturer (Section D)
TELEFLEX
reserach triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck dr.
research triangle park NC 27709
Manufacturer Contact
katharine tarplay, regulatory affai
po box 12600
research triangle park, NC 27709
9194334854
MDR Report Key4188203
MDR Text Key5160642
Report Number1044475-2014-00285
Device Sequence Number1
Product Code OGH
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 09/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number005852300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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