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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; SKIN STAPLER
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TELEFLEX MEDICAL VISISTAT 35W 6/BOX; SKIN STAPLER Back to Search Results
Catalog Number 528235
Device Problem Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2015
Event Type  malfunction  
Event Description
Complaint alleges: during a medical procedure the surgeon found metal clips stuck in the stapler.The medical procedure is unknown.However; the patient was fine and no medical intervention was necessary.No patient injury reported.
 
Manufacturer Narrative
(b)(4), device sample received by manufacturer, but investigation is still underway at time of this report.
 
Manufacturer Narrative
(b)(4).One (1) stapler from catalog number 528235 visistat 35w (b)(4) was received used, opened without original package, lot # was not confirmed, and stapler was received with remaining staples.During visual inspection it was observed that the components looked well assembled, stapler was received with trigger component pre-activated.Functional inspection: stapler was activated for full activation cycle and stuck staple in the tip was released, however, staples were not forming properly.Then stapler was activated according to the ifu product "the trigger must be squeezed all the way in" and a staple was loaded, closed & released properly without problems.Although, from the sample received the defect was observed "stuck in stapler" during visual inspection & during first activation , the root cause for this issue is considered unknown.A functional inspection was performed & no quality issues were found during the activation, the device worked properly.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.
 
Event Description
Complaint alleges: during a medical procedure the surgeon found metal clips stuck in the stapler.The medical procedure is unknown.However; the patient was fine and no medical intervention was necessary.No patient injury reported.
 
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Brand Name
VISISTAT 35W 6/BOX
Type of Device
SKIN STAPLER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 2147 8
MX   21478
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key4820835
MDR Text Key5840433
Report Number3003898360-2015-00375
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/13/2019
Device Catalogue Number528235
Device Lot Number73H1400076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/17/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/06/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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