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, Arthroscopic, Spinal and Neurological procedures.
FDA Recall Z-1022-2011 · Posted 2011-02-02
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Recalling FirmPeak Surgical
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-05-19
Date Terminated2011-04-21
Product Quantity493 units
Reason for Recall
A customer reported that a patient suffered a burn while using the device.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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