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

Model Number IPN028493

Device Problem Failure to Form Staple (2579)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product visistat 35w 6/box lot# 73m1900182 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

When the user fired a staple the staple came out from the stapler but not enough to suture the skin.Therefore, a new unit was used instead.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit 528235 visistat 35w 6/box for investigation.There were also 2 partially formed staples returned loose.The returned sample was visually examined with and without magnification.Visual examination of the returned stapler revealed that the stapler appeared used as there was biological material present on the device.The staples appear to be properly aligned.The stapler was returned with 27 staples left in the cartridge indicating that at least 8 staples have been fired by the end user.In order to complete functional inspection, the trigger was engaged by applying hand pressure to the trigger.Upon full engagement of the trigger, the first staple properly formed and fired.However, the next 3 staples were partially formed when fired.The device was disassembled and it was found that the cover block was detached from the trigger on one side.The cover block was manually reattached to the trigger and the stapler was reassembled.The next 4 staples were able to properly form and release.To simulate insertion into the skin, the remaining 19 staples were fired into a skin pad.All remaining staples were able to properly form and release.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple closure, the trigger must be squeezed all the way in." a corrective action is not required at this time as the root cause of this complaint could not be determined.It could not be determined how or when the cover block became partially detached from the trigger.All staplers are 100% inspected at manufacturing for firing at the time of assembly so it is unlikely that these issues were present at the time of manufacturing assembly.The reported complaint of "misfire/jam - staples not forming/closing" was confirmed based upon the sample received.The sample was returned with the cover block partially detached from the trigger.This prevented the stapler from consistently being able to function properly.Once the cover block was reattached to the trigger, the device functioned properly with all remaining staples fully forming and releasing from the device.All staplers are 100% inspected at manufacturing for firing at the time of manufacturing assembly.A device history record review was performed with no evidence to suggest a manufacturing related cause.It could not be determined how or when the cover block partially detached from the trigger.Therefore, the root cause of this complaint could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

When the user fired a staple the staple came out from the stapler but not enough to suture the skin.Therefore, a new unit was used instead.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12312963
• MDR Text Key: 266207200
• Report Number: 3003898360-2021-00683
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• 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: 07/28/2021

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
• Device Operator: Health Professional
• Device Model Number: IPN028493
• Device Catalogue Number: 528235
• Device Lot Number: 73M1900182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1