BEUDAMED
    FDA Enforcement Class II Terminated

    Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

    Recall: Z-0754-2019 · Reported January 30, 2019

    Enforcement

    Recall Number
    Z-0754-2019
    Event ID
    81909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 30, 2019
    Initiation Date
    January 3, 2018
    Classification Date
    January 18, 2019
    Termination Date
    October 30, 2020
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

    Reason

    There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

    Code Info

    Batch/Lot Numbers: 73A1700535, 73B1600170, 73B1700073, 73B1700523, 73B1700646, 73C1600058, 73C1600706, 73D1600482, 73F1600086, 73G1600207, 73G1600468, 73G1600573, 73G1700041, 73G1700311, 73G1700577, 73H1600509, 73H1700513, 73H1700526, 73H1700531, 73H1700532, 73J1700100, 73J1700553, 73M1600016, 73M1600027, 73M1600231

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.

    Quantity

    1962 units