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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK AUTO ENDO5 ML; APPLIER
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TELEFLEX MEDICAL WECK AUTO ENDO5 ML; APPLIER Back to Search Results
Catalog Number 543965
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2014
Event Type  malfunction  
Event Description
Complaint alleges that the applier was unable to load clips.This was discovered during use on a pt.No harm to the pt was reported.Pt current condition is reported as fine.
 
Manufacturer Narrative
Device history record (dhr) review did not show any issues related to this complaint.Failure mode "unable to load clip" was unable to be confirmed with the picture that was submitted.No other defects were observed.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determinate the root cause.Mfr will continue to monitor and trend similar complaints.
 
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Brand Name
WECK AUTO ENDO5 ML
Type of Device
APPLIER
Manufacturer (Section D)
TELEFLEX MEDICAL
rtp NC 27709
Manufacturer Contact
jasmine brown
po box 12600
durham, NC 27709
9193614124
MDR Report Key4224558
MDR Text Key5002214
Report Number3003898360-2014-00878
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number543965
Device Lot Number01G1300356
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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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