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

Catalog Number	528135
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "staple jamming".No patient involvement.
Event or Problem Description
It was reported that "staple jamming".No patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 528135 visistat 35r 6/box for investigation.Multiple staples were observed to be misaligned at the front of the cover block.The bottom component was observed to not be welded at the back of the cover block, allowing the staples to become misaligned and out of position.The bottom component was able to move when pressed, indicating no weld at all in the back left side of the cover block.Functional testing could not be performed, due to the misaligned staples.The device was disassembled and die casting anomalies on the forming tool were also discovered.Per dhr the product visistat 35r 6/box lot # 73d2400446 was manufactured on 04/09/2024 a total of (b)(4) pieces.Lot was released on 04/19/2024.Dhr investigation did not show issues related to complaint.A corrective and preventive action (capa) was opened by the manufacturing site to further investigate this issue.The capa identified the probable root cause of the incorrectly positioned bottom as inadequate manufacturing controls surrounding the ultrasonic welding process of the bottom component to the cover block component.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: WECK VISISTAT 35R 6/BOX
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23790167
• Report Number: 3003898360-2025-00912
• Device Sequence Number: 20213881
• Product Code: QQS
• UDI-Device Identifier: 04026704418190
• UDI-Public: (01)04026704418190(11)240409(17)290408(10)73D2400446(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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 73D2400446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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