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

Model Number	IPN914814
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).From the pictures attached was unable to confirm failure mode reported as "failure to function - other".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.A dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.P/n 528236 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 staplers were taken from the current production from p/n 528235 visistat 35w 6/box lot# 73e2100738 the staplers were functionally inspected and issue reported "failure to function - other" was not observed in the current manufacturing process, the staples were loaded and released correctly.The device history review for the product visistat 35w non-sterile lot # 73j2000213 was manufactured on 09/08/2020 a total of (b)(4) pieces.Lot was released on 09/18/2020.Dhr investigation did not show issues related to complaint.Failure mode "failure to function - other" could not be confirmed with picture attached, however it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.Failure mode "failure to function - other" could not be confirmed with picture attached, however it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.
Event or Problem Description
Stapler do not close the clamps or do not clamp them at all.This problem was identified when the stapler was to be used.However, since it did not work, a replacement product had to be used.This incident happened in 4 trays, so 4 staplers were problematic.There was no adverse affect.

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11992547
• Report Number: 3003898360-2021-00545
• Device Sequence Number: 3201713
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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
• Report Date (Section B): 06/03/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1