Intuitive Surgical, Inc. Recall 89641
Description: VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Intuitive Surgical, Inc. Recall 89641 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1209-2022 |
| Event ID | 89641 |
| Event Description | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam. |
| Quantity | 140,519 boxes (843,113 individual units) |
| Recall Reason | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. |
| Device Classification | 20220608 |
| Device Code Info | UDI: 00886874115664. All lots |
| Center Classification Date | 20220531 |
| Recall Initiation Date | 20220303 |
| Recalling Firm | Intuitive Surgical, Inc. |
| Initial Notification | Letter |
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