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 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product visistat 35w 6/box lot# 73h2000623 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

During the procedure of applying staples on a patient, several staples did not close.There was no consequence for the patient.We used another stapler with success.

Manufacturer Narrative

(b)(4).The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned stapler revealed that the trigger was returned partially engaged.The sample appeared used as there was biological material on the device.The staples appeared properly aligned in the device.The stapler was re ceived with 24 staples left in the device indicating that at least 11 staples were fired by the end user.Functional inspection was performed by attempting to fire staples from the device.Using hand pressure, the trigger was engaged.Upon full engagement of the trigger, the first staple was able to properly form and release from the device.These actions were repeated for the next 2 staples with the same result.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.All 21 remaining staples were able to properly fire and close into the skin pad.All staples were fired from the device with no difficulty.No defects or anomalies were observed.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 device.The stapler was able to properly fire all remaining staples.The reported complaint of "misfire/jam - staples not forming/closing" 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.No defects or anomalies were observed with the sample.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

During the procedure of applying staples on a patient, several staples did not close.There was no consequence for the patient.We used another stapler with success.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12127186
• MDR Text Key: 260215644
• Report Number: 3003898360-2021-00621
• 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: 06/24/2021

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: 73H2000623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1