Recall record at a glance
| Official record | Z-0059-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Teleflex Medical |
| Report date | Nov 8, 2017 |
| Recall initiation date | Oct 18, 2017 |
| Quantity | 3904 units |
| Location | Research Triangle Park, NC, United States |
Official 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.
Why the product was recalled
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 information
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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