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

Catalog Number	528135
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2026
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.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 "the skin was not captured properly when applying the staple".No report of patient harm or injury.
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 staples appeared properly aligned and the trigger was engaged upon investigation.The trigger was not engaged prior to decontamination.The stapler was returned with 34 staples remaining in the cover block, indicating the customer fired at least 1 staple.Evidence of use in the form of biological material was not present on the device.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 fired into the air properly formed and released.Resistance was observed from the trigger.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.Upon the second fire attempt, the second and third staples fired simultaneously and failed to fully form.Excessive resistance was felt upon engagement of the trigger on the second fire attempt.14 additional staples were fired and were able to engage and close into the simulated skin; however, resistance was still felt during engagement of the trigger.The pawl was observed to be correctly assembled.Minor die stamping anomalies were discovered on the forming tool.The trigger was observed to be correctly aligned with the frame.The frame's rib was observed to have deformity where the pawl resets.A lip on the rib was observed.No additional defects were observed with the internal components.The complaint sample's frame was switched out with a lab inventory trigger and cover block.Functional testing was conducted and all the staples in the lab inventory cover block were able to fully and release without resistance.Therefore, the deformity on the rib of the frame could not be conclusively linked to why the complaint sample misfired.The tecate manufacturing site was consulted regarding the frame deformity, and the probable root cause of the misfired staple could not be conclusively determined.Per dhr the product visistat 35r 6/box lot # 73e2500728 was manufactured on 05/23/2025 a total of (b)(4) pieces.Lot was released on 06/03/2025.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." resistance was still felt during engagement of the trigger.Additionally, two staples fired simultaneously and failed to fully form.The pawl was observed to be correctly assembled.The frame's rib was observed to have deformity where the pawl resets.A lip on the rib was observed.The tecate manufacturing site was consulted regarding the frame deformity.The lip found on the back rib of the frame could not be conclusively linked to the misfiring of the staples.Additionally, it was concluded that the probable root cause of the misfired staples could not be conclusively determined based on the sample and the information provided.The reported complaint of "misfire/jamming-multiple staples firing" could be confirmed based on the sample received.Resistance was still felt during engagement of the trigger.Additionally, two staples fired simultaneously and failed to fully form.The pawl was observed to be correctly assembled.The frame's rib was observed to have a deformity where the pawl resets.A lip on the rib was observed.The trigger was observed to be correctly aligned with the frame.No additional defects were observed with the internal components.The complaint sample's frame was switched out with a lab inventory trigger and cover block.Functional testing was conducted and all the staples in the lab inventory cover block were able to fully and release without resistance.Therefore, the deformity on the rib of the frame could not be conclusively linked to why the complaint sample misfired.The tecate manufacturing site was consulted regarding the frame deformity.The lip found on the back rib of the frame could not be conclusively linked to the misfiring of the staples.Additionally, it was concluded that the probable root cause of the misfired staples could not be conclusively determined based on the sample and the information provided.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 "the skin was not captured properly when applying the staple." no report of patient harm or injury.

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 24681543
• Report Number: 3003898360-2026-00133
• Device Sequence Number: 21263939
• Product Code: QQS
• UDI-Device Identifier: 04026704418190
• UDI-Public: (01)04026704418190(11)250523(17)300522(10)73E2500728(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/24/2026

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: 73E2500728
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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