MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN)

Model Number	IPN914814
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w 6/box lot# 73j2000213 investigation did not show issues related to the complaint.
Event or Problem Description
We have received complaints after changing skin stapler from coviden to teleflex.The clamps do not adhere in the subcutaneous layer.It does not lock as it should.Have happened to many times and the customer wants financial replacement.
Event or Problem Description
We have received complaints after changing skin stapler from coviden to teleflex.The clamps do not adhere in the subcutaneous layer.It does not lock as it should.Have happened to many times and the customer wants financial replacement.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 528236 visistat 35w non-sterile for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned stapler revealed that the staples appeared properly aligned.The stapler was received with 35 staples left in the cartridge.Functional inspection was performed by attempting to fire staples from the returned stapler.Using hand pressure, the trigger was engaged.Upon full engagement of the trigger, the first staple was able to properly form and release.This was repeated four more times with the same result.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.The remaining 30 staples were all able to engage and close into the skin pad.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple closure, the trigger must be squeezed all the way in." a corrective action is not required at this time as there were no functional issues found with the returned stapler.The reported complaint of "misfire/jam-staples not forming/closing" could not be confirmed based upon the sample received.The returned stapler was able to form and release all remaining staples in the cover block.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned stapler.

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11731695
• Report Number: 3003898360-2021-00411
• Device Sequence Number: 11817349
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/14/2021

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 Model Number: IPN914814
• Device Catalogue Number: 528236
• Device Lot Number: 73J2000213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1