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	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "staple jamming".A new stapler was used to proceed with the procedure.No patient harm or injury reported.The patient's status is reported as "fine".
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 and staples were severely misaligned.The stapler was returned with approximately 34 staples remaining in the cover block, indicating that approximately at least 1 staple was fired by the customer.The trigger was returned engaged.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.Minor die stamping anomalies were discovered on the forming tool of the returned sample.The back end of the shuttle was observed to be bent inwards.The root cause of the bend of the shuttle could not be conclusively determined.The main root cause of the reported misfire and jamming was determined to be the detached saddle spring.No defects were observed with the pawl assembly.No other defects or anomalies were observed.Per dhr the product visistat 35r 6/box lot # 73j2400956 was manufactured on 09/27/2024 a total of 16,002 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 34 staples remaining in the cover block, indicating that approximately at least 1 staple was 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.The back end of the shuttle was observed to be bent inwards.The root cause of the bend of the shuttle could not be conclusively determined.The main root cause of the reported misfire and jamming was determined to be the detached saddle spring.Minor die stamping anomalies were discovered on the forming tool of the returned sample.The device was returned with the saddle spring detached from the pusher.Actions to address this issue of detached saddle springs were established as part of nonconformance, which was closed on 09-feb-2026.The sample was manufactured prior to these actions on 27-sep-2024.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 jamming".A new stapler was used to proceed with the procedure.No patient harm or injury reported.The patient's status is reported as "fine".

• 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: 24552162
• Report Number: 3003898360-2026-00114
• Device Sequence Number: 20227157
• Product Code: QQS
• UDI-Device Identifier: 14026704736284
• UDI-Public: (01)14026704736284(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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