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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO 5ML; APPLIER: GEF, GDO
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TELEFLEX MEDICAL AUTO ENDO 5ML; APPLIER: GEF, GDO Back to Search Results
Catalog Number 543965
Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2014
Event Type  malfunction  
Event Description
Alleged event: the applier failed to advance the clips during set up.There is no patient injury.The patient's condition is reported as fine.
 
Manufacturer Narrative
The device history record review (dhr) of the product auto endo5 ml, lot #01j1300038 was manufactured on 09/06/2013, a total of 288 pieces.Lot was released on 09/11/2013.Dhr investigation did not show issues related to complaint.Device sample received by manufacturer, but investigation is on-going at time of this report.The manufacturer will continue to monitor and trend related complaints.
 
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Brand Name
AUTO ENDO 5ML
Type of Device
APPLIER: GEF, GDO
Manufacturer (Section D)
TELEFLEX MEDICAL
tecate
MX 
Manufacturer (Section G)
TELEFLEX MEDICAL
prolongacion mision eusebio
tecate, b.c. CP 2 1478
MX   CP 21478
Manufacturer Contact
effie jefferson, rn
p.o. box 12600
durham, NC 27709
9194332672
MDR Report Key4014777
MDR Text Key18872035
Report Number3003898360-2014-00425
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number543965
Device Lot Number01J1300038
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/12/2014
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Patient Sequence Number1
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