CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.

Recommended Action

Per FDA guidance

On October 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by certified mail with confirmed delivery receipt stating: URGENT: MEDICAL DEVICE RECALL COOPERSURGICAL QUANTUM 2000 ELECTROSURGERY GENERATOR Dear Valued CooperSurgical Customer, CooperSurgical has issued a Medical Device Recall for 219 serial numbers of its QUANTUM 2000 Electrosurgery Generator [CooperSurgical part numbers: 909075, 909075-05 and 909075-05W]. The QUANTUM 2000 Electrosurgery Generator is used for loop electrosurgical excision procedure (LEEP) also called the loop excision of the transformation zone (LLETZ). It utilizes a very thin wire powered by an electrosurgical power supply to provide a cervical tissue specimen. CooperSurgical is issuing this medical device recall due to the possibility that the cut, coagulate, or blend function may not operate with the use of the Foot Pedal (Part Number: 109686-1 ). The nonconformity was detected during a Service and Repair activity. The affected units will work as intended with the use of the Hand-Switch Pencil and Cord (Part Numbers: 395-310/LP-50-101) to activate the cut, coagulation, or blend functions by hand control rather than foot activation using the Foot Pedal. Failure of the device to cut, coagulate, or blend tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case, which can only be averted by using the cut, coagulation, or blend functions on the Hand-Switch Pencil. Please be aware that serious injuries could occur due to the failure mode associated with this Recall. There have not been any adverse events reported to CooperSurgical due to this potential issue. Our records indicate you have purchased the affected product serial number from CooperSurgical. This recall affects 219 serial numbers manufactured between January 11, 2016 and August 17, 2017 and a corrective action has been initiated to prevent future recurrence.

Distribution

As reported by FDA

AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, ME, MA, MT, NV, NJ, NY, ND, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV