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	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w 6/box, lot# 73f1900328.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 first staple appeared misaligned.The sample appears used as there was biological material observed on the device.The stapler was returned with 39 staples left in the cover block.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, no staple fired.Multiple attempts were made, but no staples fired.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.On the next 3 attempts, staples properly fired from the device.To simulate insertion into the skin, the stapler was fired onto a skin pad.During the first 2 attempts, the staples were able to successfully fire and release into the skin pad.However, no staple fired on the next attempt.The staples were intermittently getting misaligned during functional testing which made the staples unable to properly fire.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 first staple appeared misaligned.Upon functional inspection, some staples were able to fire after the staples were manually realigned.However, when firing into the skin pad, only 2 staples were able to properly fire and release.The misalignment of the staples prevented the staples from consistently being able to properly fire from the device.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.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11339673
• Report Number: 3003898360-2021-00186
• Device Sequence Number: 16987263
• 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): 01/29/2021

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: 06/11/2024
• Device Model Number: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: 73F1900328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1