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 Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.The device history review for the product visistat 35w 6/box lot #73c1900134 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during the procedure, the customer found that after the third fired clip was not clipping properly there is a bent and reopening.The customer replaced the new product and ended the procedure.There is no adverse event and the patient was fine.

Event Description

It was reported that during the procedure, the customer found that after the third fired clip was not clipping properly there is a bent and reopening.The customer replaced the new product and ended the procedure.There is no adverse event and the patient was fine.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35w 6/box lot # 73c1900134 was manufactured on 03/06/2019 a total of (b)(4) pieces.Lot was released on 03/15/2019.Dhr investigation did not show issues related to complaint.The device has not been returned for investigation.The device history review for the product visistat 35w 6/box lot #73c1900134 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, a staple was unable to form or close properly.This was repeated two times with the same result.The stapler was disassembled and it was confirmed to have been assembled correctly.A functioning lab inventory visistat stapler was disassembled and the forming tool from the returned sample was inserted into the lab inventory stapler.The stapler was reassembled and the trigger was engaged.Three staples were able to properly form and release from the device.The forming tool from the functioning lab inventory stapler was inserted into the returned sample.Upon engagement of the trigger, the staple was unable to form properly.Next, the anvil component was tested.The anvil from the returned sample was inserted into the lab inventory stapler.The stapler was reassembled and the trigger was engaged.Three staples were tested and all were unable to form properly.The anvil from the functioning lab inventory stapler was inserted into the returned sample.Upon engagement of the trigger, three staples were able to properly form and release from the device.The sample anvil appears to be preventing the staples from forming properly.Further examination revealed that the sample anvil was a regular size anvil for visistat 35 r staplers.Upon investigation, it was observed that the staples were not forming or closing since the incorrect anvil was assembled into the returned sample.When a visistat 35 w anvil was inserted into the stapler, the stapler fired properly.Nc 60052030 was initiated in order to implement corrective actions to prevent this issue from recurring in the future.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 nonconformance has been initiated by the manufacturing site to implement corrective actions in order to prevent this issue from re curring in the future.Teleflex will continue to monitor and trend on complaints of this nature.The reported complaint of "misfire/jam-staples not forming/closing" was confirmed based upon the sample received.Upon functional inspection, the staples were unable to form properly.It was found that the stapler was assembled with a visistat 35r anvil instead of a visistat 35w anvil.When the stapler was assembled with the correct 35w anvil, the stapler fired properly.A nonconformance was initiated at the manufacturing site in order to implement corrective actions to prevent this issue from recurring in the future.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10326564
• MDR Text Key: 200427568
• Report Number: 3003898360-2020-00607
• 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: 07/20/2020

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 Expiration Date: 03/05/2024
• Device Catalogue Number: 528235
• Device Lot Number: 73C1900134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1