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	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w 6/box, lot# 73c1900104.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.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned sample revealed that the stapler was returned with two loose staples.The staples in the cover block were severely misplaced and loose.One staple was partially loaded and was sticking out of the forming tool and into the side of the stapler.No burrs were found on the loose staples.The device was disassembled for further inspection and it was observed that the bottom and the rail were detached from the cover block on one side.The pusher and the staples were loose and could easily fall out of the device.There were 23 staples remaining in the cover block indicating that at least 12 staples were fired by the end user.It appears that the bottom was not properly welded onto the cover block, which allowed the rail, pusher and staples to fall out of the stapler.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to improve the manufacturing process and prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.It appears that the bottom was not properly welded to the cover block, which allowed the rail and the staples to fall out from the stapler.A nonconformance has already been opened as a result of this issue.The received sample was manufactured prior to the corrective actions being put in place.The reported complaint of "detached staple feed assembly" was confirmed based on the returned sample.The stapler was returned with two loose staples and the staples in the cover block were severely misplaced or loose.Upon disassembly, the bottom and the rail were detached from the stapler on one side.The pusher and the staples were loose and able to fall from the device.It appears that the bottom was not properly welded to the cover block, which allowed the rail, pusher and staples to fall out from the stapler.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to improve the manufacturing process and prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.Therefore, no further actions will be required.
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.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11339539
• Report Number: 3003898360-2021-00182
• Device Sequence Number: 3372465
• 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): 01/21/2021

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: 03/04/2024
• Device Model Number: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: 73C1900104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1