da Vinci Vessel Sealer May Fail to Adequately Seal Tissue
Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.
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 recall of a surgical device with potential for operational failure if improper technique is used. No reported illnesses or injuries are mentioned in the source material. Per the severity rubric, risk-of-harm products without reported injuries are scored as High (3).
Plain-English summary
Intuitive Surgical, Inc. is recalling the VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X and da Vinci Xi models worldwide. The recall affects 140,519 boxes containing 843,113 individual units distributed across the United States and 50+ additional countries and regions.
The device can fail to adequately seal tissue if surgeons place excessive tissue in the instrument jaws prior to sealing and transection. An insufficient seal during surgery could compromise the effectiveness of the procedure.
This Class II recall was issued by the FDA. The affected product can be identified by the UDI code 00886874115664 and covers all production lots.
Healthcare facilities and surgeons using these instruments should review proper technique guidelines to ensure appropriate tissue volume is used during sealing procedures. Contact Intuitive Surgical for additional guidance on proper device use.
The recalled product
- Product
- VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- insufficient-seal
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: 00886874115664. All lots
Distribution
Distributed nationwide across the United States.
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