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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE
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TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE Back to Search Results
Catalog Number 77700
Device Problem Failure to Conduct (1114)
Patient Problem No Patient Involvement (2645)
Event Date 09/23/2014
Event Type  malfunction  
Event Description
The complaint is reported as: the clinician took the handle out of the packaging and the light did not work on the first try.Complaint states that it needed to be wiggled several times before it began to work and it appeared to work fine after that.
 
Manufacturer Narrative
The sample was returned for evaluation, however, the evaluation 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 DISPOLED DISP FO LARYNGOSCOPE HANDLE
Type of Device
LARYNGOSCOPE HANDLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer Contact
katharine tarpley
po box 12600
research triangle park, NC 27709
9194334854
MDR Report Key4172827
MDR Text Key5099494
Report Number1044475-2014-00279
Device Sequence Number1
Product Code GCI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number77700
Device Lot Number13Z2405
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/01/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/25/2014
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 Unknown
Patient Sequence Number1
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