MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISISTAT SKIN STAPLER 35R; 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	03/06/2024
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 the staple will not come out from the stapler.A new stapler was used to complete the procedure.No patient harm or injury.The patient status is reported as "normal".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "misfire/jamming - staples not releasing" could not be confirmed based upon the sample received.The customer returned one unit 528135 visistat 35r 6/box for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned stapler revealed that the staples appeared properly aligned with slight gaps between some of the staples.The stapler was returned with its trigger not engaged.There were clear signs of biological material on the device indicating the device was used by the customer.The stapler was received with 16 staples left in the cartridge, indicating that at least 19 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 properly formed and released.The stapler was then fired into a simulated skin pad to simulate insertion into the skin.The remaining 15 staples were fired and were able to engage and close into the simulated skin.The device was disassembled and die casting anomalies were discovered on the forming tool.No other defects or anomalies were observed.It was observed that saddle spring was correctly attached to the pusher, and the anvil was in the proper orientation.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.There were no functional issues found with the returned stapler.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: correction to section d.4.Udi was updated from (b)(4) to include the full udi.
Event or Problem Description
It was reported that the staple will not come out from the stapler.A new stapler was used to complete the procedure.No patient harm or injury.The patient status is reported as "normal".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19059562
• Report Number: 3003898360-2024-00357
• Device Sequence Number: 6752068
• Product Code: QQS
• UDI-Device Identifier: 14026704631770
• UDI-Public: 14026704631770
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: 73F2300576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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