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

Catalog Number 528235

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).A visual or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Verification of failure mode reported in the current manufacturing process was conducted as follows: 13 staplers were taken from the current production from p/n 528235 visitant 35w 6/box lot# 73g2000441 the staplers were functionally inspected and issue reported "misfire/jamming - staples not firing" was not observed in the current manufacturing process, the staples were loaded and released correctly.The device history review for the product visitant 35w 6/box lot #73c1900104 investigation did not show issues related to the complaint.Other remarks: corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.The customer complaint cannot be confirmed due to the product sample is not available to perform a proper investigation and determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that (b)(6) 2020 in (b)(6) hospital the first staple could not be fired during usage on the patient for femoral head replacement.It was found the staple was misalign.

Manufacturer Narrative

(b)(4).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 stapler revealed that the sample was returned with the staples severely misaligned.The stapler was returned with 29 staples left in the cover block, indicating that at least 6 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 fired properly.However, no more staples were able to fire from the device.It appears that the misalignment of the staples is preventing the staples from moving down the track and into the forming tool.The stapler was disassembled , and it was confirmed to have been assembled correctly.No other defects or anomalies were observed.It could not be determined exactly how or what caused the staples to misalign.A capa was previously opened by the manufacturing site to further investigate visistat jamming issues.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." 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.One sample was returned with the staples in the returned device misaligned.Upon functional inspection, the misalignment of the staples prevented the staples from firing properly.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.Other remarks:.

Event Description

It was reported that (b)(4) 2020 in (b)(6) hospital the first staple could not be fired during usage on the patient for femoral head replacement.It was found the staple was misalign.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10403526
• MDR Text Key: 202796712
• Report Number: 3003898360-2020-00634
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Catalogue Number: 528235
• Device Lot Number: 73C1900104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1