MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISISTAT SKIN STAPLER 35R; STAPLE, REMOVABLE (SKIN)

Catalog Number	528135
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staple will not come out from the stapler.A new stapler was used to complete the procedure.No patient harm or injury.The patient status is reported as "normal".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "misfire/jamming - staples not releasing" was confirmed based upon the sample received.The customer returned one unit 528135 visistat 35r 6/box for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned stapler revealed that the staples appear to be severely misaligned; one of the staples was positioned above the rest in the cover block.The stapler was returned with its trigger not engaged.There were signs of biological material on the device indicating the device was used by the customer.The stapler was received with 6 staples left in the cover block, indicating that at least 29 staples were fired by the customer.A functional inspection was performed on the sample by attempting to fire staples from the returned stapler.Upon full engagement of the trigger, the first staple formed and partially released.The first staple fired, formed, and did not release initially in the air.The first staple was tucked under the next staple in the cover block; a light force was used to fully release the staple.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.On the second fire attempt, staple fully formed and released in the skin pad.After the second fire, it was observed that next the staple at the front of the device was clearly misaligned.On the third fire attempt, one unformed staple fell out and one fully formed staple was fired into skin pad.The remaining two staples were fired into the skin pad and the staples fully formed and released.The device was disassembled and die casting anomalies were discovered on the forming tool.No other defects or anomalies were observed.It was observed that saddle spring was correctly attached to the pusher, and the anvil was in the proper orientation.It was observed that the cover block was sourced from cavity 5.The source of the staple misalignment could not be conclusively determined.Additionally, the ifu for this product, 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 device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that the staple will not come out from the stapler.A new stapler was used to complete the procedure.No patient harm or injury.The patient status is reported as "normal".

• Brand Name: WECK VISISTAT SKIN STAPLER 35R
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19060588
• Report Number: 3003898360-2024-00353
• Device Sequence Number: 6752599
• Product Code: QQS
• UDI-Device Identifier: 14026704631770
• UDI-Public: 14026704631770
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 528135
• Device Lot Number: 73F2300576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown