The Recall Desk
HighFDA (Devices)·Z-1210-2022·Announced 2022-06-08

Surgical Instrument Seal Defect Recall: da Vinci Energy SynchroSeal

Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.

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: FDA Class II medical device recall for a functional defect that could impair surgical sealing. No injuries have been reported and the hazard is theoretical, placing it at score 3 per the rubric.

Plain-English summary

Intuitive Surgical is recalling the da Vinci Energy SynchroSeal single-use surgical instrument (8mm, REF 480440). The recall affects approximately 47,972 individual units distributed worldwide.

The device may fail to seal properly when excessive tissue is placed in the instrument jaws prior to sealing and transection. This could compromise the intended sealing function during surgical procedures.

No injuries or illnesses have been reported in association with this defect.

The recalled product

Product
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • seal-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 00886874117309. All lots

Distribution

Distributed nationwide across the United States.

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