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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX WECK VISISTAT 35R 6/BOX; SKIN STAPLER
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TELEFLEX WECK VISISTAT 35R 6/BOX; SKIN STAPLER Back to Search Results
Catalog Number 528135
Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2014
Event Type  malfunction  
Event Description
Complaint alleges: the stapler has staples in the cartridge, but it is not firing.No patient injury.
 
Manufacturer Narrative
Device sample was not returned to manufacturer.No lot # available.A visual or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Dhr review could not be conducted since the lot number was not provided.Complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.The manufacturer will continue to monitor and trend relating complaints.
 
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Brand Name
WECK VISISTAT 35R 6/BOX
Type of Device
SKIN STAPLER
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer (Section G)
TELEFLEX
prolongacion mision eusebio
Manufacturer Contact
elaine burkle, rn, ra
p.o. box 12600
rtp,, NC 27709
9194334957
MDR Report Key3896462
MDR Text Key20269394
Report Number3003898360-2014-00306
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number528135
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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