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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN)
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TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN) Back to Search Results
Catalog Number 528236
Device Problem Failure to Form Staple (2579)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the skin stapler does not work properly: all the staplers are not working properly.When the customer is using it, no matter where on the body of the patient, the staplers are deforming and curl to the outside.So impossible to use.They are constantly throwing them away and use another one they have on the shelf.
 
Manufacturer Narrative
Qn#(b)(4).This report was submitted by mistake due to incorrect information.Report (b)(4) is retracted.
 
Event Description
It was reported that the skin stapler does not work properly: all the staplers are not working properly.When the customer is using it, no matter where on the body of the patient, the staplers are deforming and curl to the outside.So impossible to use.They are constantly throwing them away and use another one they have on the shelf.
 
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Brand Name
VISISTAT 35W NON-STERILE
Type of Device
STAPLE, REMOVABLE (SKIN)
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10248089
MDR Text Key198143290
Report Number3003898360-2020-00546
Device Sequence Number1
Product Code GDT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number528236
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received07/08/2020
Supplement Dates Manufacturer Received07/13/2020
Supplement Dates FDA Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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