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

Model Number	IPN008820
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	05/19/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Stapler lost staples while being used.Fell from stapler.
Event or Problem Description
Stapler lost staples, while being used fell from stapler.
Additional 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
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11968593
• Report Number: 3003898360-2021-00541
• Device Sequence Number: 3173242
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 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
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1