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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 Problem Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 06/22/2015
Event Type  malfunction  
Event Description
The customer alleges that while preparing for use on a patient , the staff discovered that the cartridge locking pins were missing.No patient injury reported.
 
Manufacturer Narrative
(b)(4).The device sample was not returned for evaluation at the time of this report.
 
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
The customer alleges that while preparing for use on a patient, the staff discovered that the cartridge locking pins were missing.No patient injury reported.
 
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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 drive
research triangle park NC 27709
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key4892127
MDR Text Key17307545
Report Number1044475-2015-00238
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,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2015
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? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/31/2015
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 Initial
Patient Sequence Number1
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