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U.S. Department of Health and Human Services

Class 2 Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan.

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  Class 2 Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan. see related information
Date Initiated by Firm May 03, 2013
Date Posted July 01, 2013
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1628-2013
Recall Event ID 65205
510(K)Number K012669  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502

-Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288

-CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494

-Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325,

-Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633

Electrosurgical cutting and coagulation device and accessories.

-CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745

-CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483,

-Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446

-Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446

-ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762

-Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512

-LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512

-Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325

-Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765

-MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494

-Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293

-Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673

-Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765

-SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734

-SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266

-Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663

-StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595

-Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663

-Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765

-TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486

-TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283

-Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486

-VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466

-VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512

-VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455

-VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293,

-VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318

-VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512

-VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356,

-VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409

-VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639

-VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512

-Vulcan Sa
Code Information 122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.
Recalling Firm/
Manufacturer		 Surgical Instrument Service And Savings, Inc.
2747 Sw 6th St
Redmond OR 97756-7109
For Additional Information Contact Rich Wynkoop
866-866-7477
Manufacturer Reason
for Recall		 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
FDA Determined
Cause 2		 Packaging process control
Action MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Quantity in Commerce 447 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
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