Recall Z-0754-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Teleflex Medical
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.
| Date | Jan 3, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 w |
| Quantity | 1962 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM Teleflexmedical, Inc., Apr 8, 2016 |