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

Catalog Number	528235
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
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 prior to use "staple jamming".No patient involvement.
Event or Problem Description
It was reported that prior to use "staple jamming".No patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported complaint of misfire/jamming - info not provided 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 properly aligned.The stapler was returned with 30 staples remaining in the cover block, indicating that at least five staples were fired by the customer.The trigger was returned partially engaged.No clear evidence of use in the form of biological material was present on the device.As part of functional inspection, multiple attempts were made to fire staples by engaging the trigger of the stapler using hand pressure, the first five staples fired properly.The remaining were inserted into a simulated skin pad.It was observed that several staples did not form correctly.Die casting anomalies were observed on the forming tool.It could not be conclusively determined what caused the staples to misalign.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate misfiring and jamming in visistat staplers.The forming tool component was also under the same investigation.Investigation still ongoing at the time of this report.Additionally, the ifu for this product states, "to obtain optimum staple closure, the trigger must be squeezed all the way in." a dhr review was performed, and no evidence was found to suggest a manufacturing related cause.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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17699679
• Report Number: 3003898360-2023-01303
• Device Sequence Number: 12420308
• Product Code: QQS
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/23/2023

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: 73J2200174
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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