MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISISTAT 35R 6/BOX; STAPLE, REMOVABLE (SKIN)

Catalog Number	528135
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
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 verification of failure mode reported in the current manufacturing process was conducted as follows: 20 staplers were taken from the current production from p/n 528135 visistat 35r 6/box lot# 73f2600291 the staplers were functionally inspected (fired) and issue reported "bent/deformed - staple forming assembly" was not observed in the current manufacturing process, the staples were loaded and released correctly.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "a incident occurred on (b)(6) 2026.In the orthopedics department, a defective stapler was used.It jammed and the staples failed to come out." additional information received reports that "the wound edges were inflamed immediately post-operatively, but the evolution of the condition was positive" [for the patient].No medical intervention related to this incident was required.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25678406
• Report Number: 3003898360-2026-00288
• Device Sequence Number: 13192241
• Product Code: QQS
• UDI-Device Identifier: 14026704736284
• UDI-Public: (01)14026704736284(11)251109(17)301108(10)73L2500091(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/09/2026

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
• Device Catalogue Number: 528135
• Device Lot Number: 73L2500091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2025
• 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: NOT REPORTED
• Patient Sex: Unknown