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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "staple jamming." no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The reported complaint could not be confirmed by the photos.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 and staples were severely misaligned.The stapler was returned with approximately 25 staples remaining in the cover block and one unformed loose staple, indicating that approximately at least 9 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.Upon functional testing, the stapler was engaged and no staples fired.The stapler was attempted to be fired multiple times, and no staples were released due to the severe misalignment of the staples.Additionally, the pusher was observed to not move forward upon engagement of the trigger.The pusher was freely moving in the cover block.The device was disassembled, and it was observed that the saddle spring 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.Non-conformance was opened to address saddle spring disconnection.Per dhr the product visistat 35r 6/ box lot#: 73j2400956 was manufactured on 09/27/2024 a total of (b)(4) pieces.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 reported complaint of "misfire/jamming - info not provided" could be confirmed based upon the sample received.Visual examination of the returned sample revealed that the pusher appeared loose in the cover block and staples were severely misaligned.The stapler was returned with approximately 25 staples remaining in the cover block and one unformed loose staple, indicating that approximately at least 9 staples were fired by the customer.The stapler was attempted to be fired multiple times, and no staples were released due to the severe misalignment of the staples.The device was disassembled, and it was observed that the saddle spring was fully disconnected from the pusher.Die casting anomalies were discovered on the forming tool of the returned sample.The device was returned with the saddle spring detached from the pusher.Non-conformance was opened by the manufacturing site to further evaluate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "staple jamming." no patient involvement.
Additional Manufacturer Narrative
(b)(4).

• 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: 24023590
• Report Number: 3003898360-2026-00015
• Device Sequence Number: 18380771
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 01/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown