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

Model Number	IPN008819
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Some staples did not come out smoothly from the device therefore, a new unit was used instead.
Additional Manufacturer Narrative
Qn# (b)(4).Although a lot number was not initially reported, a potential lot number was obtained through the sales history.The potential lot is 73a2000273.Per dhr the product visistat 35w 6/box lot# 73a2000273 was manufactured on 01/14/2020 a total of (b)(4) pieces.Lot was released on 01/28/2020.Dhr investigation did not show issues related to complaint.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 stapler revealed that the staples appeared properly aligned.The sample was returned with its trigger partially engaged.The stapler was received with 8 staples left in the cartridge, indicating that at least 27 staples were fired by the end user.The returned sample appeared used as there was biological material present on the device.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 with the same result for the next staple.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.The remaining six 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/jamming - staples not firing" 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.
Event or Problem Description
Some staples did not come out smoothly from the device therefore, a new unit was used instead.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12127254
• Report Number: 3003898360-2021-00623
• Device Sequence Number: 3592843
• Product Code: GDT
• UDI-Device Identifier: 04026704600762
• UDI-Public: 04026704600762
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/24/2021

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: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1