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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
Model Number IPN914814
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/21/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device history review of the product visistat 35w non-sterile lot# 73a2100112 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event or Problem Description
Staples come off after two days and are difficult to place in the stapler, there are a risk for the patient (infection).
 
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Brand Name
VISISTAT 35W NON-STERILE
Common Device Name
STAPLE, REMOVABLE (SKIN)
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12568846
Report Number3003898360-2021-00946
Device Sequence Number4053584
Product Code GDT
UDI-Device Identifier34026704630302
UDI-Public34026704630302
Combination Product (Y/N)N
Initial Reporter CountryBE
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/21/2021
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
Operator of Device Health Professional
Device Model NumberIPN914814
Device Catalogue Number528236
Device Lot Number73A2100112
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/21/2021
Initial Report FDA Received Date10/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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