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	08/13/2023
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 "staples were found jamming prior to use on the patient." no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 528235 visistat 35w 6/box for investigation.Visual examination of the returned sample revealed that the first staple appeared misaligned.The stapler was returned with 42 staples remaining in the cover block.The trigger was returned engaged and evidence of use in the form of biological material was present on the device.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon functional inspection, no staples fired.It appeared that the staple misalignment prevented the remaining staples from consistently firing.The stapler was disassembled, 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 reported complaint was confirmed based upon the sample received.Visual examination revealed that the first staple appeared to be misaligned.Upon functional inspection, it appeared that the staple misalignment prevented the remaining staples from firing.The sample was disassembled, and die casting anomalies on the forming tool was discovered.No other defects or anomalies were observed.Each stapler is fired three times and then 100% inspected for proper staple alignment at the manufacturing site.For this reason, it is unlikely that the issue was present at the time of assembly.A dhr review was performed with no evidence to suggest a manufacturing related cause.It could not be conclusively determined what caused the staples to misalign.A non-conformance was opened by the manufacturing site to further investigate the issue of visistat staplers failing to function properly.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "staples were found jamming prior to use on the patient." no patient involvement.

• 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: 17641299
• Report Number: 3003898360-2023-01286
• Device Sequence Number: 18137323
• 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 Catalogue Number: 528235
• Device Lot Number: 73F2200179
• 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: 10/03/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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