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	12/22/2025
Type of Reportable Event	Malfunction
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).
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 528135 visistat 35r 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned stapler showed one jammed staple partially formed in the mouth of the cover block.The stapler was returned with the trigger engaged, and there was evidence of biological material on the device.The stapler was received with 25 staples left in the cover block, indicating the customer fired at least 10 staples.The jammed staple was removed from the device.After the removal of the staple, damage was observed on the mouth of the cover block.The damage resembled a dent/scrape and was near the area where the staple was jammed.Functional inspection was performed on the sample.When engaging the trigger, a staple was able to be fired into the air with no issues.The saddle spring was observed to be correctly attached to the pusher and functioning properly.No other defects or damage were observed on the device.The manufacturing site was contacted about the observed damage and no conclusive determination for the dent/scrape could be determined.The damage is consistent with user misuse, but it could not be conclusively linked to manufacturing or user error.Per dhr the product visistat 35r 6/box lot#: 73k2400259 was manufactured on 10/11/2024 a total of (b)(4) pieces.Lot was released on 10/29/2024.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" was confirmed based upon the sample received.The stapler was returned with the trigger engaged and one staple jammed and partially formed in the mouth of the cover block.The jammed staple was removed from the device.After the removal of the staple, damage was observed on the mouth of the cover block.The damage resembled a dent/scrape and was near the area where the staple was jammed.Functional inspection was performed on the sample.When engaging the trigger, a staple was able to be fired into the air with no issues.No other damage was observed on the device.The manufacturing site was contacted about the observed damage and no conclusive determination for the dent/scrape could be determined.The damage is consistent with user misuse, but it could not be conclusively linked to manufacturing or user error.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: 24099989
• Report Number: 3003898360-2026-00043
• Device Sequence Number: 10397024
• Product Code: QQS
• UDI-Device Identifier: 04026704418190
• UDI-Public: (01)04026704418190(11)241011(17)291010(10)73K2400259(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 73K2400259
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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