The Recall Desk
HighFDA (Devices)·Z-0257-2022·Announced 2021-11-24

LEEP PRECISION Electrosurgical System Coagulation Function May Fail

CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.

What this means for you

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 an FDA Class II surgical device with a functional defect that could lead to intraoperative complications requiring medical intervention, but no reported injuries or incidents are documented in the source, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

CooperSurgical's LEEP PRECISION Integrated System, model LP-10-120 (120V), is being recalled due to a defect affecting the coagulation function.

The coagulate function may not operate properly when using the hand switch. Failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control intraoperative bleeding and complete the surgical case.

The recall affects 1,587 units distributed in the US and internationally across 35+ countries. Affected facilities should contact CooperSurgical for information regarding affected serial numbers and appropriate corrective actions.

The recalled product

Product
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Electrosurgical Device
Hazard
  • device-malfunction
  • coagulation-failure
  • uncontrolled-bleeding

Distribution

Distributed nationwide across the United States.

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