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

Catalog Number	528235
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (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.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the user released the handle after firing a staple, but it did not return to the original position during use.He/she replaced the stapler with a new unit, but the same issue occurred.Therefore, the third unit was used to complete the procedure.No injury to the patient occurred".Associated mdr # 3003898360-2025-00721.
Event or Problem Description
It was reported that "the user released the handle after firing a staple, but it did not return to the original position during use.He/she replaced the stapler with a new unit, but the same issue occurred.Therefore, the third unit was used to complete the procedure.No injury to the patient occurred".See associated mdr# 3003898360-2025-00721.
Additional Manufacturer Narrative
(b)(4).Additional information received on 14 oct 2025 states that the correct product code is 528235.The lot number has been corrected to "unknown" the customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and with out magnification.The stapler was returned with the trigger partially engaged, and there was no evidence of biological material on the device.One staple was partially formed in the mouth of the stapler.The stapler was received with 33 staples left in the cover block, indicating at least 2 staples were fired by the customer.A functional inspection was performed on the sample by attempting to fire staples from the returned stapler.Upon full engagement of the trigger, the first staple fully formed and released.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.The remaining staples were fired and were able to engage and close into the simulated skin.The bottom component of the complaint sample was observed to be positioned incorrectly.A non-conformance was opened by the manufacturing site to further investigate this issue.Resistance was not felt at the trigger during functional testing; however, due to the observed defect it is possible the customer observed jamming and resistance prior to the return of the sample.No defects were observed with the frame or the pawl assembly.Die casting anomalies were observed on the forming tool.No additional abnormalities were observed.The reported complaint of "jamming - resistance felt at trigger" was confirmed based upon the sample received.The bottom component of the complaint sample was observed to be positioned incorrectly.Upon full engagement of the trigger, the first staple fully formed and released.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.The remaining staples were fired and were able to engage and close into the simulated skin.Resistance was not felt at the trigger during functional testing; however, due to the observed defect it is possible the customer observed jamming and resistance prior to the return of the sample.No defects were observed with the frame or the pawl assembly.The stapler was received with 33 staples left in the cover block, indicating at least 2 staples were fired by the customer.A non-conformance was opened by the manufacturing site to further evaluate this issue.Die casting anomalies were observed on the forming tool.A device history record review could not be performed as no lot number was provided by the customer.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23097840
• Report Number: 3003898360-2025-00722
• Device Sequence Number: 18471828
• Product Code: QQS
• UDI-Device Identifier: 04026704418190
• UDI-Public: (01)04026704418190(11)250115(17)300114(10)73A2500520(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: 528235
• Device Lot Number: UNKNOWN
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown