MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN)

Model Number	IPN914814
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w non-sterile lot# 73m2000051 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
The staples do not hold to the skin and a loose suture is seen with scar disunion.Unfortunately, i do no have any photos or sample.The defect was noticed immediately upon application.The staples do not hold and the skin becomes invaginated.The risks for the patient were an immediate or later disunion leading to a healing and aesthetic defect.Local care was provided with directed healing had to be implemented at home and there may be a need for remote revision surgery for cosmetic damage.

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12325670
• Report Number: 3003898360-2021-00755
• Device Sequence Number: 2806503
• Product Code: GDT
• UDI-Device Identifier: 14026704672896
• UDI-Public: 14026704672896
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• Number of Events Summarized: 1
• 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): 08/10/2021

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 Number: IPN914814
• Device Catalogue Number: 528236
• Device Lot Number: 73M2000051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention