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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED RECHARGABLE HANDLE SET; LARYNGOSCOPE HANDLE
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TELEFLEX MEDICAL RUSCH TRULED RECHARGABLE HANDLE SET; LARYNGOSCOPE HANDLE Back to Search Results
Catalog Number 0055500
Device Problems Failure to Conduct (1114); Optical Problem (3001)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 01/29/2015
Event Type  malfunction  
Event Description
The customer alleges that the handle failed to light properly and found not charging properly.The alleged issue was detected during pre-testing.No patient injury reported.
 
Manufacturer Narrative
(b)(4).Potential lot numbers reported - 12447v2, 091150v2.The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
RUSCH TRULED RECHARGABLE HANDLE SET
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
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key4535738
MDR Text Key5543836
Report Number1044475-2015-00082
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 User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0055500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/30/2015
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 Unknown
Patient Sequence Number1
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