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Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans ...

FDA Device Recall #Z-0059-2018 — Class II — October 18, 2017

Recall Summary

Recall Number Z-0059-2018
Classification Class II — Moderate risk
Date Initiated October 18, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Teleflex Medical
Location Research Triangle Park, NC
Product Type Devices
Quantity 3904 units

Product Description

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog Number PCVSC5 The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion conduits (trocars), the 2.9mm insulated Shafts are inserted percutaneously with the assistance of an Introducer needle tool tip. The Shaft is then advanced retrograde through a 5mm, or larger, port to facilitate the extracorporeal attachment of interchangeable Tool Tips. These interchangeable tools can be used to grasp, retract, manipulate, cut, coagulate and deliver Hem-o-lok¿ ligating clips to soft tissue. Each Percuvance System Handle includes an integrated male cautery adapter that can be connected to most monopolar electrosurgical units (ESU) via a standard 4mm monopolar cable.

Reason for Recall

Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.

Lot / Code Information

(a) Catalog Number PCVJG5, Lot Numbers: 73E1700794, 73G1700271, 73G1700515, 73H1700081, 73H1700367 (b) Catalog Number PCVMD5, Lot Numbers: 73E1700796, 73G1700273, 73H1700083 (c) Catalog Number PCVHCA5, Lot Numbers: 73E1700798, 73H1700084 (d) Catalog Number PCVGG5, Lot Numbers: 73E1700793, 73G1700272, 73H1700082, 73H1700247 (e) Catalog Number PCVSC5, Lot Number: 73H1700569

Other Recalls from Teleflex Medical

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Z-0703-2020 Class II HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial ... Oct 30, 2019
Z-0688-2020 Class II Arrow EZ-IO Intraosseous Vascular Access System... Oct 8, 2019
Z-0689-2020 Class II Arrow EZ-IO Intraosseous Vascular Access System... Oct 8, 2019
Z-0690-2020 Class II Arrow EZ-IO Intraosseous Vascular Access System... Oct 8, 2019
Z-0496-2020 Class II WECK AutoEndo5, Automatic Hem-O-Lok Clip Applie... Oct 4, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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