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

Model Number IPN028493

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device history review for the product visistat 35w 6/box lot# 73k2100591 investigation did not show issues related to the complaint.

Event Description

The staples do not stay applied on the skin.They fall.

Event Description

The staples do not stay applied on the skin.They fall.

Manufacturer Narrative

Qn# (b)(4).Per dhr the product visistat 35w 6/box lot # 73k2100591 was manufactured on 10/18/2021 a total of (b)(4) pieces.Lot was released on 10/29/2021.Dhr investigation did not show issues related to complaint.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 staplers were taken from the current production from p/n 528235 visistat 35w 6/box lot# 73c2200991 the staplers were functionally inspected (fired) and issue reported "misfire/jam-staples not forming/closing" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of fmea-08-028-rev 05 was performed and the failure mode is already including it, no update is required.No problem found on sample.One (1) skin stapler was received under part number 528235; the lot number cannot be confirmed as it was received without its original packaging.During visual inspection was observed: all components assembled correctly, staples aligned.A functional test was performed by undoing 29 staples containing the cover block forming correctly and released without any difficulty.Based on the received sample, the failure mode reported as " misfire/jam-staples not forming/closing " cannot be confirmed since no defect was found in the sample.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: 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: 14116110
• MDR Text Key: 289317642
• Report Number: 3003898360-2022-00130
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028493
• Device Catalogue Number: 528235
• Device Lot Number: 73K2100591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1