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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX AUTO END5 ML; APPLIER
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TELEFLEX AUTO END5 ML; APPLIER Back to Search Results
Catalog Number 543965
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2014
Event Type  malfunction  
Event Description
Alleged event: when the physician attempted to fire the clips he said the jaws did not move into the closed position to accept the clip and they were completely coming out of the applier when he would advance it.He also said the handle did not ratchet or have the last audible ping.The patient's condition is reported as fine.
 
Manufacturer Narrative
The device history record review indicated that the product auto endo5 ml, lot#73e1400168 was manufactured on 05/13/2014 a total of (b)(4) pieces.Lot was released on (b)(4) 2014.Dhr investigation did not show issues related to complaint.The device sample has not been returned to the manufacturer at the time of this report.The manufacturer will continue to monitor and trend related complaints.
 
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Brand Name
AUTO END5 ML
Type of Device
APPLIER
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer Contact
effie jefferson, rn
po box 12600
durham, NC 27709
9194332672
MDR Report Key4219054
MDR Text Key4999169
Report Number3003898360-2014-00517
Device Sequence Number1
Product Code HBT
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 Physician
Type of Report Initial
Report Date 07/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number543965
Device Lot Number73E1400168
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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