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	12/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w 6/box, lot# 73l1900065.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) 2020, 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 staples appear aligned.The sample appears used as there was biological material observed on the device.The stapler was returned with 15 staples left in the cover block indicating that at least 20 staples were fired by the end user.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 formed and fired.The next staple did not properly form and was partially fired.After this misfire, the staples appeared to become misaligned.On the next 3 attempts, no staples fired.The following attempts had staples intermittently firing properly due to the misalignment.It appeared that the misalignment of the staples was preventing the staples from moving down the track and into the forming tool.An attempt was made to manually realign the staples , but the staples were unable to be realigned.The stapler was disassembled , and it was confirmed to have been assembled correctly.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 aligned.However, upon functional inspection, the staples became misaligned and were unable to consistently fire from the device.The misalignment of the staples prevented any staples from firing.The sample was disassembled , and 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.
Event or Problem Description
It was reported that (b)(6) 2020, the staple was found jamming and could not be fired prior to the patient.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11339717
• Report Number: 3003898360-2021-00181
• Device Sequence Number: 11606079
• 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): 02/05/2021

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: 11/03/2024
• Device Model Number: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: 73L1900065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1