Recall Z-1022-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Peak Surgical
PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthrosco
| Date | Feb 2, 2011 (initiated May 19, 2009) |
| Status | Terminated |
| Reason | A customer reported that a patient suffered a burn while using the device. |
| Root cause | Other |
| Action | Peak Surgical notified afftected customers by phone on May 19, 2009. They were notified of the product, the problem, and the action to be taken. Peak Surgical sales representatives removed PlasmaBlade EXT devices from consignees affected by the recall. |
| Quantity | 493 units |
| Distribution | Worldwide Distribution - United States including CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, and WAand the countries of Turkey and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES Peak Surgical, Inc., Dec 3, 2008 |