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	02/22/2024
Type of Reportable Event	Malfunction
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.
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 part number 528135 visistat 35r 6/box lot number 73c2400176 the staplers were functionally inspected (fired) and issue reported "misfire/jam - staples not releasing" was not observed in the current manufacturing process, the staples were loaded and released correctly.Dhr investigation did not show issues related to complaint.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.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "misfire/jamming - staples not releasing" was 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 first staple was severely misaligned and sticking out of the front of the device.The stapler was returned with the trigger partially engaged, and there were signs of biological material on the device.The stapler was received with 14 staples left in the cartridge including the staple sticking out, indicating that at least 21 staples were fired by the customer.A functional inspection was performed on the sample by attempting to fire staples from the returned stapler.Prior to functional inspection, the first staple stuck at the front of the device was manually removed.To simulate insertion into the skin, the remaining 13 staples were fired into the skin pad and the staples fully formed and released.Dried biological material was released from the stapler onto the skin pad as the staples were fired.The device was disassembled and die casting anomalies were discovered on the forming tool.Additionally, it was observed the forming tool had dried blood on it.No other defects or anomalies were observed.Saddle spring was attached to the pusher; however, the saddle spring was observed to be crooked.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.The source of the staple misalignment could not be conclusively determined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to evaluate this issue.Other remarks: n/a.Corrected data: 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.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19059327
• Report Number: 3003898360-2024-00360
• Device Sequence Number: 6752562
• 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: 04/16/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/24/2024
• 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