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	07/20/2023
Type of Reportable Event	Malfunction
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.
Additional Manufacturer Narrative
(b)(4).
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.
Additional Manufacturer Narrative
(b)(4).The reported complaint of misfire/jamming-misaligned staples was confirmed based upon the sample received.The customer returned one unit of 528235 visistat 35w 6/box for investigation.Visual examination of the returned sample revealed that the staples appeared severely misaligned.The stapler was returned with 33 staples remaining in the cover block, indicating that at least two staples were fired by the customer.The trigger was returned partially engaged.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, it appeared that the staple misalignment prevented the remaining staples from consistently firing correctly.In total, five staples were fired.Three staples did not form properly.Two staples fired properly but did not release.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.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.It could not be conclusively determined what caused the staples to misalign.An investigation was initiated to further investigate the issue.The investigation is still on-going.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17692164
• Report Number: 3003898360-2023-01321
• Device Sequence Number: 17653445
• 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): 08/20/2023

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: 03/16/2026
• Device Catalogue Number: 528235
• Device Lot Number: 73C2100574
• 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: 08/20/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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