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

Catalog Number	528135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 528135 visistat 35r 6/box for investigation.Visual examination of the returned sample revealed that the pusher appeared loose in the cover block.The stapler was returned with 0 staples remaining in the cover block, indicating that at least 35 staples were fired by the customer.The trigger was returned unengaged.There was evidence of use in the form of biological material present on the device.Proper functional testing could not be completed due to no staples remaining in the device.The device was disassembled, and it was observed that the saddle spring was disconnected on one side of the cover block and was fully disconnected from the pusher.Die casting anomalies were discovered on the forming tool of the returned sample.No other defects or anomalies were observed.Nc was opened to address the saddle spring disconnection issue.Per dhr the product visistat 35r 6/box lot # 73j2400956 was manufactured on 09/27/2024 a total of (b)(4).Lot was released on 10/11/2024.Dhr investigation did not show issues related to complaint.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." the device was returned with the saddle spring detached on one side.Nc was opened by the manufacturing site to further evaluate this issue.The reported complaint of "bent/deformed parts - staples" could not be confirmed based upon the sample received.Visual examination revealed that the sample was returned with zero staples remaining in the cover block.Proper functional testing could not be completed due to no staples remaining.The stapler was disassembled, and it was observed that the saddle spring was out of position on one side of the cover block and was disconnected from the pusher.Nc was opened by the manufacturing site to further evaluate this issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "staple deformed".A new device was used to complete the procedure.No report of patient harm or injury.The patient status is reported as "fine".

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23907138
• Report Number: 3003898360-2025-00938
• Device Sequence Number: 21071620
• Product Code: QQS
• UDI-Device Identifier: 04026704418190
• UDI-Public: (01)04026704418190(11)240927(17)290926(10)73J2400956(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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: 73J2400956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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
• Patient Sex: Unknown