MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISISTAT SKIN STAPLER 35R; 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	12/03/2024
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 "it was found that the stapler is not firing during use on a patient.The patient's condition is find and no medical intervention required.".
Additional Manufacturer Narrative
(b)(4).One unit of visistat 35r (p/n 528135, lot 73d2400447) was returned for evaluation following a report of misfire/jamming with misaligned staples.Visual inspection of the returned device identified multiple staples misaligned at the front of the cover block.Further examination revealed that the bottom component was not welded at the back of the cover block, allowing movement of the component and resulting in staple misalignment.Functional testing could not be performed due to the observed staple misalignment.Device disassembly also identified die-casting anomalies on the forming tool.Review of the device history record for the complained lot (manufactured 04/09/2024; released 04/24/2024) did not identify manufacturing nonconformances related to the reported issue.An additional investigation specific to this failure mode was not initiated, as the same failure mechanism had previously been investigated under mdr 3003898360-2024-01396 for the same finished good.That investigation resulted in the opening of a capa.The capa identified the probable root cause as inadequate manufacturing controls associated with the ultrasonic welding process of the bottom component to the cover block, leading to improper positioning of the bottom component.Based on the available information, the reported failure mode is consistent with a previously identified manufacturing issue that is being addressed under the existing capa.No new or different failure mechanism was identified in this complaint.The issue remains subject to ongoing monitoring and trending.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "it was found that the stapler is not firing during use on a patient.The patient's condition is find and no medical intervention required.".

• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23742684
• Report Number: 3003898360-2025-00904
• Device Sequence Number: 8469489
• Product Code: QQS
• UDI-Device Identifier: 04026704418190
• UDI-Public: (01)04026704418190(11)240409(17)290408(10)73D2400447(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): 11/11/2025

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: 73D2400447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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
• Patient Sex: Unknown