Quantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure
CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where functional failure creates potential for serious intraoperative complications (uncontrolled bleeding during surgery), but no actual injuries or illnesses are reported in the source text. FDA Class II classification supports this assessment.
Plain-English summary
CooperSurgical has issued a Class II recall of the Quantum 2000 Electrosurgical Generator (Part Number 909075) due to a malfunction in the coagulate function when the hand switch is used. The affected units include 193 devices with specific serial numbers.
When the coagulate function fails to operate with the hand switch, surgical teams may be unable to control bleeding during procedures. This can require extended operative time and additional medical intervention to manage intraoperative bleeding and complete the surgical case.
The recalled devices have been distributed nationwide in the United States and internationally to 38 countries including Canada, Mexico, the United Kingdom, Germany, China, India, and others. Healthcare facilities that use these generators should verify their device serial numbers against the recall list and contact CooperSurgical for replacement or service information.
Surgeons and operating room staff should verify their equipment serial numbers and follow guidance from CooperSurgical regarding remediation or discontinuation of use pending a permanent fix.
The recalled product
- Product
- Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 193
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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