MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number	IPN008819
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w 6/box, lot# 73c2000048 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that (b)(6) 2021, the staple was found jamming and could not be fired prior to the patient.
Event or Problem Description
It was reported that (b)(6) 2021, the staple was found jamming and could not be fired prior to the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the sample appears used as there was biological material observed on the device.There is a notable gap in the cover block before the next staple.A staple also appears lodged horizontally in the distal end of the cover block, preventing the staples from firing.The stapler was returned with 30 staples left in the cover block indicating that at least 5 staples were fired by the end user.In order to perform functional inspection, an attempt was made to manually remove the horizontal staple , but the attempt was unsuccessful.The sample was disassembled for further inspection.An attempt to realign the staples was made and the staples were moved up in the cover block.Upon reassembly, an attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, the first staple properly fired.Four more attempts were made , and all staples properly formed and released.To simulate insertion into the skin, the staples were fired into a skin pad.All 25 remaining staples were able to properly fire and release into the skin pad.Although the staples were able to be realigned and properly fired from the device, it appeared that the misalignment of the staples was preventing the staples from moving down the track and into the forming tool.No other defects or anomalies were observed with the device.It could not be determined what exactly caused the staples to misalign.A nonconformance has been opened by the manufacturing site to further investigate visistat jamming issues.It could not be determined what caused the staples to misalign.A nonconformance has been opened by the manufacturing site to further investigate this visistat jamming issue.The reported complaint of "misfire/jamming - staples not firing" was confirmed based upon the sample received.Visual examination revealed that the staples were misaligned.Upon functional inspection, the sample was disassembled to realign the staples and move the staples up in the cover block so they could be fired from the device.Upon reassembly, the stapler was able to properly form and fire all remaining staples.Although the staples could properly fire after realignment, it appears that the misalignment of the staples prevented them from firing.No other defects or anomalies were observed.It could not be determined what caused the staples to misalign.A nonconformance has been opened by the manufacturing site to further investigate visistat jamming issues.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11339696
• Report Number: 3003898360-2021-00187
• Device Sequence Number: 3372468
• Product Code: GDT
• UDI-Device Identifier: 04026704600762
• UDI-Public: 04026704600762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 03/02/2025
• Device Model Number: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: 73C2000048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1