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

Model Number	IPN914814
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device history review of the product visistat 35w non-sterile lot# 73a2100112 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
Staples come off after two days and are difficult to place in the stapler there is a risk for the patient (infection).
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 528236 visistat 35w non-sterile for investigation.The sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears typical.The staples appeared properly aligned.No defects or anomalies were observed.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 successfully fired from the device.This was repeated with the same result for hte next five staples.To simulate insertion into the skin, the remaining staples were fired into a simulated skin pad.All remaining staples were successfully applied to the skin pad.The device was returned with 41 staples remaining in the cover block.The staples were checked after 72 hours and no staples re-opened in 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 c losure, 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 device.The reported complaint of "failure to function - staple re-opens" was not confirmed based on the returned sample.All staples from the returned stapler were able to successfully fire from the device.Thirty-five staples were successfully fired into a simulated skin pad.After 72 hours, the staples were remaining firmly in place with no evidence of re-opening.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.No functional issues were observed with the returned device.We will continue to monitor and trend on this issue.
Event or Problem Description
Staples come off after two days and are difficult to place in the stapler there is a risk for the patient (infection).

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12568901
• Report Number: 3003898360-2021-00945
• Device Sequence Number: 17157164
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/21/2021

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 Model Number: IPN914814
• Device Catalogue Number: 528236
• Device Lot Number: 73A2100112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown