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

Model Number IPN008820

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history review for the product visist at 35w non-sterile lot# 73g2000119 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 Description

Stapler lost staples while being used.Fell from stapler.

Event Description

Stapler lost staples, while being used fell from stapler.

Manufacturer Narrative

Qn# (b)(4).The customer returned one unit 528236, visistat 35w non-sterile for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned sample revealed, that there was one loose staple remaining in the cover block.The pusher and shuttle were both loose within the cover block as well.Upon further inspection, it was observed, that the bottom and rail were detached on one side of the cover block.It appears that the bottom was not properly welded onto the cover block.Which allowed the components within the cover block to become loose and fall out of the stapler.A nonconformance has been opened by the manufacturing site, as a result of this issue.

• Brand Name: VISISTAT 35W NON-STERILE
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11968593
• MDR Text Key: 255209737
• Report Number: 3003898360-2021-00541
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN008820
• Device Catalogue Number: 528236
• Device Lot Number: 73G2000119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1