Da Vinci surgical system operative components with E-brake retainer pin defect
Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for serious patient injury including tissue injury, crushing injury, and bleeding. Although no hospitalization reports are cited in the source, the mechanism of failure (uncontrolled motion during surgery) presents substantial risk of serious harm, meeting the Severe threshold.
Plain-English summary
Intuitive Surgical, Inc. is recalling Da Vinci ASSY, PSS, SP1098 operative components (Part Number 380601) distributed worldwide. The recall affects 454 units identified by the listed serial numbers.
The defect involves an E-brake retainer pin that may not function correctly. In the event of a structural column failure, the defective pin would prevent proper E-brake engagement, potentially resulting in uncontrolled motion of the surgical system. Additionally, if the pin moves or backs out of position, it may cause restricted column range of motion and/or uncontrolled motion.
These failures could cause patient tissue injury, crushing injury, or bleeding. Healthcare facilities using affected units should contact Intuitive Surgical for instructions on identifying their systems and obtaining corrective action.
The affected serial numbers are listed in the UDI documentation (UDI: 00886874114605). Worldwide distribution includes the United States and multiple countries including Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, and Romania.
The recalled product
- Product
- Da Vinci ASSY, PSS, SP1098, Part Number: 380601
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- uncontrolled-motion
- mechanical-failure
- tissue-injury
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 (20)
- UDI: 00886874114605. Serial Numbers: 605408
- 606848
- 612328
- 628399
- 609353
- 614073
- 617794
- 616769
- 10008062
- 635659
- 631694
- 638771
- 641430
- 694998
- 645433
- 643209
- 954097
- 656203
- 764644
- 656319
Distribution
Distributed nationwide across the United States.
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