MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35R 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number IPN028492

Device Problem Failure to Align (2522)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product visistat 35r 6/box lot# 73j1900168 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

The clip is misaligned.(unit: operating room).

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35r 6/box lot # 73j1900168 was manufactured on 09/09/2019 a total of (b)(4) pieces.Lot was released on 09/23/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit 528135 visistat 35r 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned stapler revealed that the sample was returned with its trigger partially engaged.The staples appear properly aligned.The stapler was received with 29 staples left in the cartridge indicating that at least 6 staples were fired by the end user.Functional inspection was performed by attempting to fire staples from the returned stapler.Using hand pressure, the trigger was engaged.Upon full engagement of the trigger, the first staple was able to properly form and release.This was repeated with the same result for the next 4 staples.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.The remaining staples were all able to engage and close into the pad.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple c losure, the trigger must be squeezed all the way in." a corrective action is not required at this time as there were no functional issues found with the returned stapler.The reported complaint of "misfire/jamming-misaligned staples" could not be confirmed based upon the sample received.The returned stapler was able to form and release all remaining staples in the cover block.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned stapler.

Event Description

The clip is misaligned.(unit: operating room).

• Brand Name: VISISTAT 35R 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11684630
• MDR Text Key: 246011912
• Report Number: 3003898360-2021-00347
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631770
• UDI-Public: 14026704631770
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028492
• Device Catalogue Number: 528135
• Device Lot Number: 73J1900168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1