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

Catalog Number	528235
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(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 "staples were found jamming during use on the patient".No patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "staples were found jamming during use on the patient".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit of 528235 visistat 35w 6/box for investigation.Visual examination of the returned sample revealed that its staples were properly aligned.The stapler was returned with 32 staples remaining in the cover block, indicating that the customer fired at least 3 staples.The trigger was returned engaged.No clear evidence of use in the form of biological material was present on the devices.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.The first 3 staples formed properly but were not releasing properly and had to be removed manually.The stapler was disassembled, and the sample's anvil was switched with a lab inventory anvil.Three staples were fired.All three staples formed properly but did not release properly and had to be manually removed.The stapler was disassembled again, and the sample's forming tool was switched with a lab inventory forming tool.Three staples were fired.All staples formed and released properly.To simulated insertion into the skin, the remaining staples were fired into a skin pad.All staples formed and inserted properly.The stapler was disassembled again, and it was confirmed to have been assembled correctly.Die casting anomalies were observed on the forming tool.No other defects or anomalies were observed with the device.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "to obtain optimum staple closure, the trigger must be squeezed all the way in." the complaint was confirmed based upon the sample received.Upon functional inspection, staples did not consistently form correctly.The sample was disassembled and die casting anomalies on the forming tool were discovered.No other defects or anomalies were observed.It could not be conclusively determined what caused the staples to misfire.A non-conformance was opened by the manufacturing site to further investigate the issue of wide visistat staplers failing to function properly.The forming tool component is under investigation as part of the non-conformance.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: WECK VISISTAT SKIN STAPLER 35W
• 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: 17690003
• Report Number: 3003898360-2023-01269
• Device Sequence Number: 6032565
• Product Code: QQS
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 528235
• Device Lot Number: 73A2100746
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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