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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKSTAT STAPLE EXTRACTOR 12/BOX
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TELEFLEX MEDICAL WECKSTAT STAPLE EXTRACTOR 12/BOX Back to Search Results
Catalog Number 525980
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2014
Event Type  malfunction  
Event Description
Company alleges: it was reported that the metal tips are twisting after 5 to 6 staples are removed.No patient injury reported.Patient current condition is unknown.
 
Manufacturer Narrative
A device history record (dhr) review did not show any issues related to this complaint.No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time due to the lack of defective product it is not possible to determine the source of the defect reported.Therefore, customer complaint cannot be confirmed and determine the root cause.The manufacturer will continue to be monitoring trending of similar complaints.
 
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Brand Name
WECKSTAT STAPLE EXTRACTOR 12/BOX
Type of Device
STAPLE EXTRACTOR
Manufacturer (Section D)
TELEFLEX MEDICAL
tecate
MX 
Manufacturer (Section G)
TELEFLEX MEDICAL
prolongacion mision eusebio
tecate, b.c.
MX  
Manufacturer Contact
jasmine brown
po box 12600
rtp, NC 27709
9193614124
MDR Report Key3956965
MDR Text Key17388937
Report Number3003898360-2014-00404
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number525980
Device Lot Number01G1300266
Was Device Available for Evaluation? No
Date Manufacturer Received05/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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