—#170279

Product

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K153063
Affected lot / 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

The firm, Teleflex, sent an "Urgent Medical Device Recall" letter dated 1/3/2019 to its customers on 01/03/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1.If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com or hand it to your sales representative. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-01-03
Terminated: 2020-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.