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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 of catalog number 528235 visistat 35w (b)(4) was received used, opened without original packaging, lot # was not confirmed, stapler was received with remaining staples; staples was not observed misaligned.Functional inspection: stapler was fired for full activation cycle according to the ifu product "the trigger must be squeezed all the way in" and a staple was released properly.However; during activation the trigger component was a little hard to be activated.Stapler was opened and was observed that the cover block component was not placed properly.Cover block component was placed properly & then stapler was activated.Seventeen staples were loaded, formed & released properly.Based on sample evaluation the failure mode "stuck in stapler" reported by the customer was not confirmed with received sample.Although; an alternate condition was observed during the functional test; trigger a little hard for activate.This condition does not affect the release of the staples.According with results obtained during functional testing; stapler was activated in different form and no quality issues were found.
 
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 Key4820845
MDR Text Key5841589
Report Number3003898360-2015-00374
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 Number73H1400189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/24/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/11/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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