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

Catalog Number 528235

Device Problem Failure to Form Staple (2579)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product visistat 35w 6/box lot# 73j1900729 investigation did not show issues related to the complaint.

Event Description

Reported issue: clip will bounce back.

Event Description

Reported issue: clip will bounce back.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35w 6/box lot # 73j1900729 was manufactured on 09/27/2019 a total of (b)(4) pieces.Lot was released on 10/17/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the staples appeared misaligned.The sample also appeared used as there was biological material observed on the device.The stapler was returned with 10 staples left in the cover block indicating that 25 staples were fired by the end user.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, the first staple properly formed and fired from the device.Another attempt was made, but the next staple was unable to load properly due to the misaligned staples.It appeared that the misalignment of the staples was preventing the staples from moving down the track and into the forming tool.After removing the improperly loaded staple, it appeared that the staples realigned themselves.The next 3 staples were able to properly form and fire from the device.To simulate insertion into the skin, the staples were then fired into a skin pad.All 5 remaining staples were able to fire into the skin pad.It could not be determined what exactly caused the staples to misalign.A capa was previously opened by the manufacturing site to further investigate visistat jamming issues.It could not be determined what caused the staples to misalign.A capa was previously opened by the manufacturing site to further investigate visistat jamming issues.The reported complaint of "misfire/jamming - staples not firing" was confirmed based upon the sample received.Visual examination revealed that the staples were misaligned.Upon functional inspection, the misalignment of the staples prevented the staples from firing.Once the staples appeared to realign themselves, all remaining staples fired properly from the device.No other defects or anomalies were observed.It could not be determined what caused the staples to misalign.A capa was previously opened by the manufacturing site to further investigate visistat jamming issues.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11065571
• MDR Text Key: 223451178
• Report Number: 3003898360-2020-01061
• Device Sequence Number: 1
• Product Code: GDT
• 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: 12/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 528235
• Device Lot Number: 73J1900729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.